Effectiveness of an Individualized Comprehensive Weight Management Program in Perimenopausal Women: An Open-label Randomized Control Trial

ABSTRACT

Background:

Weight management is essential during menopause to manage symptoms, prevent metabolic diseases, and enhance quality of life. Intensive lifestyle interventions can be helpful for comprehensive weight loss. This study assessed the efficacy of such an intervention during menopausal transition.

Methodology:

A total of 160 perimenopausal women were randomized to the intervention (n = 80) and the control arm (n = 80). The intervention arm consisted of a combination of hypocaloric, low-fat, high-protein, and high-fiber diet, along with physical activity, psychological support, and behavioral modification techniques, while standard care was provided for the control arm.

Results:

After a follow-up of 6 months, 134 participants were retained for the analysis. Participants showed notable reductions in a median change in weight, body mass index, waist circumference (P < 0.01), waist-to-hip ratio (P < 0.05) and fat percentage (P < 0.01), along with improved blood pressure. Favorable changes were also seen in biochemical markers such as median change in glycated hemoglobin, very low-density lipoprotein (VLDL), total cholesterol, and triglycerides (P < 0.01); and VLDL (P < 0.05). Dietary habits shifted toward lower energy and fat intake (P < 0.01), with increased moderate-intensity and leisure activities (P < 0.05) and improved depression and anxiety scores (P < 0.01). Across intervention arm, 42.5% of the participants achieved significant weight loss (>5% of the baseline weight) while only 2.5% in the control arm.

Conclusion:

The intensive lifestyle intervention effectively improved weight, metabolic markers, and psychological well-being among perimenopausal women, emphasizing its significance for comprehensive health management in this demographic.

INTRODUCTION

The menopausal transition is marked by hormonal hormonal fluctuations and physiological changes that are often associated with weight gain and increased risk of obesity-related health complications.[1] These hormonal disturbances and body composition alterations, specifically increased abdominal adiposity and lean mass loss, predispose menopausal women to weight gain and metabolic disturbances.[2,3] Furthermore, menopausal changes are often associated with impaired psychological health and changing lifestyle-related habits, such as unhealthy eating habits, decreased physical activity levels, emotional eating due to mood swings, and disturbed sleep patterns, further exacerbating the risk of weight gain.[4,5]

Lifestyle-based interventions are considered the cornerstone of weight management.[6] Studies employing these interventions, individually or in combination, have demonstrated effectiveness in managing weight and reducing the risk of obesity-related diseases in the general population.[7,8] However, studies focusing on weight loss intervention among menopausal women, are limited. Considering the unique transitional changes associated with the menopausal phase, lifestyle interventions for weight management might have varied results and require intensive and tailored approaches to overcome the challenges particular to these women.[9,10] Intensive lifestyle intervention, characterized by holistic approaches tailored to individual needs, setting small and achievable goals, and reinforcing long-term behavioral changes, can be practical for significant and sustainable weight loss among menopausal women.[11]

However, the efficacy of intensive lifestyle interventions remains unexplored, specifically among menopausal women in Indian settings, given the differences in physiological, psychological, and cultural aspects compared to western population.[12] Therefore, this randomized controlled trial (RCT) aimed to evaluate the effectiveness of an Individualized Comprehensive Lifestyle Intervention for weight management. It has been designed to target the unique challenges associated with weight management through a robust methodology, including tailored interventions, realistic goal-setting, and long-term behavior change strategies during menopause. This study hypothesized that the Individualized Comprehensive Lifestyle Intervention is significantly more effective in achieving sustainable and successful weight loss outcomes among perimenopausal women.

METHODOLOGY

Study design

This parallel-group, open-label, RCT was conducted to assess the efficacy of an Individualized Comprehensive Lifestyle Intervention for weight loss among perimenopausal women. The ethical clearance of the study was approved by the Institute Ethics Committee and registered with the Clinical Trials Registry-India (CTRI/2022/05/042599). Informed consent was taken from participants prior to enrollment. The study design, methodology and reporting followed the CONSORT guidelines.[13] The primary objective was to study the efficacy of an individualized comprehensive weight management program for clinically significant weight loss in perimenopausal women.

Study participants

Perimenopausal women aged 40–55 years with an intact uterus, ≥1 functioning ovary, and ≥1 menstrual period in the past 12 months attending the outpatient department of the medicine unit, were screened for eligibility based on further inclusion and exclusion criteria. The women with body mass index (BMI) between 25.0 and 39.9 kg/m², who could read and speak Hindi or English and were willing to participate with access to mobiles, were considered for enrollment. While women using oral or injectable hormonal contraception, tamoxifen, tibolone, and raloxifene in the previous 3 months or having a secondary cause of obesity (like hypothyroidism, Cushing’s disease, polycystic ovarian syndrome) or any infections, advanced end-organ damage or chronic diseases: renal/hepatic failure, any malignancy were excluded. Women who reported recent intake of medications known to affect body weight, such as drugs acting on the central nervous system, cathartics, thyroid supplements, diuretics, and selective serotonin reuptake inhibitors, or women presenting any psychosocial contraindications such as bulimia nervosa, anorexia nervosa, substance abuse, clinically significant depression or under current psychiatric care were also excluded.

Sample size calculation

Tandon et al. reported the mean weight loss in the intervention arm after 24 weeks of lifestyle intervention to be −11.9 kg and in the control arm to be −5.4 kg.[14] In this study, the standard deviation (SD) for weight at baseline was reported as 8.9, considering weight loss is more skewed than weight at baseline, we assumed a common SD for weight loss as 11 units.

At power of 90% and α as 0.05, the patients required in each arm were 61 and considering an attrition rate of 20%, the trial size was calculated as 153 participants. Therefore, a total of 160 perimenopausal obese women were recruited, 80 participants per arm.

Randomization and blinding

Patients fulfilling the inclusion and exclusion criteria were randomized in a 1:1 ratio. Randomization was performed through the use of a computer-generated list of random numbers. A permuted block design was used for randomization to ensure balance in each block. Treatment assignment was concealed in consecutively numbered sealed envelopes. Patients and clinicians were aware of the treatment group allocation and followed group-specific counseling protocol.

Allocation concealment

Treatment assignments were concealed in consecutively numbered sealed envelopes, opened sequentially on patient enrolment. The contamination in the two arms was avoided by counseling them at different times and locations.

Intervention

Based on the group allocation after randomization, each participant was given either the standard therapy or the individualized comprehensive lifestyle intervention for weight management.

Standard therapy

Standard care included dietary counseling (energy deficit dietary pattern, advice to follow moderate-intensity physical activity, and pharmacological intervention as per the indication (as decided by the treating physician). Throughout the 6-month study, participants were not contacted through phone calls or text messages or provided additional guidance on diet or physical activity. They were contacted for a follow-up assessment at the end of the 6 months.

Women-centric weight management module

The evidence and consensus-based clinical practice guidelines were developed to address the management of overweight and obesity in midlife women. A team of experts in different fields, such as medicine, gynecology, psychology, nutrition, and exercise, used the Delphi method to address the unique aspects of this phase and develop an individualized comprehensive lifestyle intervention for weight management.[11,12,15,16] The weight management module consisted of a total of eight counseling sessions: 2 individual counseling sessions and six telephonic sessions spread across 6 months. The individual counseling session comprised intensive dietary and physical activity sessions undertaken by a nutritionist and behavior therapy sessions by a psychologist. Patient education materials such as flyers, cue cards, and posters were used to create awareness about session-specific topics. A brief description of the same is summarized in Box 1.

Box 1.

Individualized comprehensive weight management program for perimenopausal women

Medical management: A detailed history and clinical assessment were done to analyze the stage of obesity and associated comorbidities. Based on the assessment, the patient was advised medical assistance. Besides, patients were treated for comorbid conditions such as diabetes, hypertension, dyslipidemia, and metabolic syndrome. This treatment was as per the standard protocol.

Dietary counseling: Dietary intervention focused on caloric reduction and improving the quality of the diet, emphasizing eating behavior. Every participant was given a daily diet plan according to her physical activity level (sedentary, moderately active, and highly active) and choice/cultural acceptance. A daily calorie deficit of 500 calories was targeted. Participants were counseled once every month. They were asked to maintain a diet diary.

Physical activity advice: Progressive physical activity was advised with the aim of reducing sedentary behavior. Participants were advised to do at least 150 min (2 h and 30 min) of moderate-intensity, aerobic physical activity a week. They were advised to perform aerobic activities in episodes of at least 10 min and preferably spread throughout the week (Mishra et al., 2012).

Behavior modification: Participants were counseled on behavioral techniques to enhance compliance for sustainable weight loss outcomes. A realistic weight goal for the patient was defined, and techniques such as self-monitoring, stimulus control, eating behavior, problem-solving, self-esteem, motivation, and maintenance were reinforced through bi-monthly contact with the patients.

Compliance

Participants were adequately and regularly motivated to comply with the intervention schedules. Dietary compliance was ensured by asking the participant to maintain daily diet recall on the food dairy. Likewise, compliance with physical activity was ensured by asking them to maintain a daily activity log in the activity tracker. Regular education and counseling regarding the harmful effects of obesity were done to keep them motivated. This technological component and the support group helped solve associated barriers, enhancing compliance.

Data collection

Demographic and menopausal history

Demographic details such as age, dwelling, education, and occupation status of the participant and head of the family were recorded at the first meeting. Furthermore, menstrual status was asked and then was categorized as per the Stages of Reproductive Aging Workshop category into premenopausal, perimenopausal, and postmenopausal women.[17]

Anthropometric parameters such as weight, height, waist circumference (WC), hip circumference (HC), and waist-to-hip ratio (WHR) were recorded in minimal clothes. Height and weight were measured using the SECA digital column weight and height scale up to two decimal places. The participants stood barefoot, with feet slightly apart and the back of the heels, buttocks, shoulder blades, and head touching the vertical bar of the scale. WC was measured at the horizontal plane midway between the lowest ribs and the iliac crest. HC was measured at the level of the largest lateral extension of the hips using nonstretchable tape.

Body composition was analyzed using a bioelectrical impedance analyzer (bodivis eight-electrode biospace Body Composition Analyzer). Participants were asked to remove shoes and socks, extra clothes, and metallic items before standing on the machine’s platform over the metallic electrodes of the machine while holding the handle. The resistance or “impedance” set against gender, age, and height was used to calculate body fat percentage.

Biochemical parameters included fasting glucose, glycosylated hemoglobin, and lipids such as low-density lipoprotein (LDL), very low density lipoprotein (VLDL), high-density lipoprotein (HDL), total cholesterol, and triglycerides were done after an overnight fast using professional kits.

Dietary habits were assessed through a 24-h intake recall and food frequency questionnaire administered by trained dieticians. Time of intake, food description, and amount of food eaten were recorded. Various types of standardized utensils were used to assist in recalling and assessing the portion size of the food consumed.

Physical activity pattern was assessed using the validated and reliable tool Madras Diabetes Research Foundation- Physical Activity Questionnaire (MPAQ).[18]

Psychological health was assessed using the Depression and Anxiety Scale-Short version 21.[19]

Outcome measures

Clinically significant weight loss (5%–10%) among obese perimenopausal women was assessed at 6 months. Furthermore, changes in anthropometric, biochemical, and lifestyle-related such as dietary intake, physical activity status, and psychological parameters were assessed after 6 months.

Statistical analysis

Quantitative variables with a normal distribution were reported as mean ± standard deviation, while those with skewed distributions were presented as median with Interquartile Range (IQR). Categorical data were expressed as frequency with percentages. The Chi-square or Fisher’s exact test was used to determine associations between qualitative variables. An unpaired t-test or Wilcoxon rank-sum test was employed to compare quantitative characteristics between the two groups. Within-group pre- to post-intervention comparisons were conducted using the paired t-test or Wilcoxon’s signed-rank test. The intention-to-treat (ITT) analysis was also conducted to validate the results of the per-protocol analysis.

RESULTS

A cohort of 300 perimenopausal women underwent screening for eligibility based on inclusion and exclusion criteria. Subsequently, 160 obese women were screened and randomly assigned to either the intervention (n = 80) or control (n = 80) arm between June 2022 and October 2023 [Figure 1]. Following a 6-month follow-up period, the study retained 134 participants, with 26 individuals dropping out (9 in the intervention group and 17 in the control arm). The reasons for dropout included inability to attend follow-up appointments at the hospital (n = 10), lack of response to contact attempts (n = 7), non-adherence to weight management recommendations (n = 4), relocation to another state with inability to return (n = 2), medical withdrawal due to surgery (n = 2), and the death of one participant during the study period. Therefore, data were analyzed for 134 perimenopausal women (63 in the control and 71 in the intervention arm).

Figure 1.

CONSORT diagram for the study

Demographic characteristics of the participants

The baseline characteristics of participants are summarized in Table 1. The mean age for participants in the control and intervention groups was 45.8 ± 4.3 years and 45.7 ± 4.2 years, respectively. Over 60% of the women in both groups possessed high school education, identified as homemakers, and were within the middle socioeconomic status (SES) category. Furthermore, approximately half of the participants in both arms reported a parity of three or more, while over 45% of women in both groups were in the postmenopausal stage. Baseline comparisons revealed no statistically significant differences between the control and intervention groups regarding age, parity, education, occupation, SES, and menopausal status.

Table 1.

Demographic characteristics of the study participants

Variables	Control (n=80)#	Intervention (n=80)#	P
Age (Mean±SD)	45.88±4.35	45.68±4.20	0.76*
Age (years)
Category 1 (40–45)	38 (47.50)	34 (42.50)	0.19**
Category 2 (46–50)	25 (31.25)	35 (43.75)
Category 3 (51–55)	17 (21.25)	11 (13.75)
Education
Graduate and above	14 (17.50)	9 (11.25)	0.38**
Intermediate	16 (20.00)	13 (16.25)
High school or below	50 (62.50)	58 (72.5)
Occupation
Housewife	62 (77.50)	58 (72.5)	0.58**
Employed	18 (22.50)	22 (27.5)
SES
Upper	5 (6.25)	3 (3.75)	0.84**
Upper middle	20 (25.0)	20 (25.0)
Lower middle	35 (43.75)	39 (48.7)
Lower	20 (25.0)	18 (22.5)
Dwelling
Metropolitan	47 (58.75)	45 (56.25)	0.95**
Urban	22 (27.5)	24 (30.0)
Semi-urban	7 (8.75)	8 (10.0)
Rural	4 (5.00)	3 (7.5)
Parity
<3	31 (38.75)	39 (48.75)	0.26**
More than equal to 3	49 (61.25)	41 (51.25)
Menopause status
Premenopausal	14 (16.25)	21 (26.25)	0.28**
Perimenopausal	29 (36.25)	21 (26.25)
Postmenopausal	37 (47.5)	38 (47.5)

*Two-sample t-test, **Fisher’s exact test, ^#Values are Mean±SD or frequency, n (%). SES: Socioeconomic status, SD: Standard deviation

Anthropometric parameters of the participants at baseline and end line

Following a successful 6-month administration of the individualized comprehensive weight management program, statistical differences in anthropometric parameters were observed within the intervention and control groups [Table 2]. While participants in the control group demonstrated improvements in anthropometric parameters, the intervention group exhibited statistically significant differences in weight, BMI, WC, and WHR. In the control group, the median weight change was −1.0 kg (interquartile range [IQR]: −2, −0.2), while in the intervention group, it was −3.4 kg (IQR: −4.4, −2.3), with a statistically significant P < 0.001. Weight loss in the intervention group was significant after adjusting for the baseline weight (−2.66, confidence interval [CI]: −3.36, −1.95), P < 0.001 [Supplementary Table 1]).

Table 2.

Anthropometric outcome variables and blood pressure at baseline and endpoint in the intervention and control groups

Parameters	Control (n=63) Mean±SD/Median (IQR)	Intervention (n=71) Mean±SD/Median (IQR)	P
Weight (kg)
Baseline	70.11±9.6	71.2±9.2	0.48
Follow-up	69.42±9.8	67.6±8.6	0.26
Median change	−1 (−2–−0.2)	−3.4 (−4.4–−2.3)	<0.01
BMI (kg/m2)
Baseline	29.80±3.62	30.04±3.60	0.70
Follow-up	29.50±3.68	28.51±3.34	0.10
Median change	−0.47 (−0.84–0.08)	−1.41 (−1.88–−0.96)	<0.01
WC (cm)
Baseline	94.19±8.39	94.54±8.92	0.82
Follow-up	93.22±8.87	90.30±7.92	0.04
Median change	−1.6 (−2.6–−0.7)	−3.5 (−5–−2.5)	<0.01
Waist-to-hip ratio
Baseline	0.94±0.069	0.95±0.072	0.27
Follow-up	0.94±0.071	0.94±0.082	0.78
Median change	0.004 (−0.007–0.009)	−0.003 (−0.017–0.008)	<0.05
Body composition
Muscle mass (kg)
Baseline	22.02±2.72	22.26±2.46	0.59
Follow-up	22.68±3.28	22.70±2.61	0.97
Median change	0.3 (−0.2–1.1)	0.5 (−0.3–1)	0.69
Body fat (%)
Baseline	43.29±5.31	43.71±5.23	0.64
Follow-up	42.15±5.55	41.28±4.89	0.34
Median change	−1.1 (−2.1–0.2)	−2.3 (−3.4–−1.4)	<0.01
Blood pressure
Systolic blood pressure (mmHg)
Baseline	131.85±18.91	132.11±14.75	0.93
Follow-up	130.09±17.01	124.77±11.85	0.04
Median change	−3 (−8–4)	−6 (−11–−2)	<0.01
Diastolic blood pressure (mmHg)
Baseline	83.33±11.84	83.56±7.8	0.89
Follow-up	80.82±9.69	80.14±7.7	0.64
Median change	−2 (−7–2)	−3 (−7–1)	0.52

For normally distributed variables, the two-sample t-test is used and values are presented as Mean±SD. For nonnormally distributed variables, the two-sample Wilcoxon rank-sum (Mann–Whitney) test is used and values are presented as Median (IQR). SD: Standard deviation, BMI: Body mass index, IQR: Interquartile range, WC: Waist circumference

Supplementary Table 1.

Comparison for weight loss at 6 months between both the arms after 6 months

Weight loss at 6 months	Unadjusted coefficient (95% CI)	Adjusted coefficient (95% CI)a
Group
Intervention	−2.68 (−3.39–−1.97), P<0.001	−2.66 (−3.36–−1.95), P<0.001
Control	Reference	Reference
Weight at baseline	−0.049 (−0.093–−0.005), P=0.026	−0.045 (−0.083–−0.008), P=0.018

^aAfter adjusting for baseline weight. CI: Confidence interval

The lifestyle intervention group demonstrated substantial improvements in WC (−3.5 kg [IQR: −5, −2.5] vs. −1.6 [IQR: −2.6, −0.7], [P < 0.01]), WHR (P < 0.05) and body fat percentage (P < 0.01). The median difference in systolic blood pressure (−6 mmHg [−11, −2] vs. −3 mmHg [−8, 4], [P < 0.01]) was statistically better in the intervention group compared to the control group.

Biochemical parameters of the participants at baseline and end line

The changes in biochemical parameters are summarized in Table 3. After the administration of a 6-month lifestyle intervention, statistically significant improvements were seen at follow-up in VLDL (27.08 ± 10.7 mg/dL vs. 30.88 ± 11.03 mg/dL, [P < 0.05]) triglycerides (134.4 ± 53.9 mg/dL vs. 154.24 ± 54.1 mg/dL, [P < 0.05]) and total cholesterol levels (165.8 ± 33.2 mg/dL vs. 181.1 ± 29.2 mg/dL, [P < 0.01]). In addition, significant median changes were observed in glycated hemoglobin (P < 0.01), LDL (P < 0.05), VLDL (P < 0.01), total cholesterol (P < 0.01), and triglycerides (P < 0.01) among intervention group participants.

Table 3.

Biochemical parameters at baseline and endpoint in intervention and the control group

Biochemical parameters
Parameters	Control (n=63) Mean±SD/Median (IQR)	Intervention (n=71) Mean±SD/Median (IQR)	P
Fasting blood glucose (mg/dL)
Baseline	98.7±22.5	103.6±27.5	0.26
Follow-up	99.9±28.5	96.8±18.9	0.45
Median difference	0.3 (−7.8–6)	−3.1 (−13.5–5)	0.20
HbA1c (%)
Baseline	6.08±1.08	6.10±1.16	0.92
Follow-up	6.14±1.00	5.92±0.86	0.19
Median difference	0.02 (−0.2–0.31)	−0.12 (−0.33–0.13)	<0.01
LDL (mg/dL)
Baseline	99.38±31.06	101.14±32.7	0.75
Follow-up	100.79±27.63	93.11±27.66	0.11
Median difference	3 (−12–16)	−4 (−20–8)	<0.05
HDL (mg/dL)
Baseline	45.9±10.55	46.67±9.76	0.68
Follow-up	49.2±11.07	46.70±9.82	0.16
Median difference	5 (−3–8)	0 (−6–6)	<0.01
VLDL (mg/dL)
Baseline	30.22±11.36	32.76±14.12	0.26
Follow-up	30.88±11.03	27.08±10.7	<0.04
Median difference	1 (−5–6)	−3 (−10–1)	<0.01
Triglycerides (mg/dL)
Baseline	152.13±56.1	159.9±64.6	0.45
Follow-up	154.24±54.1	134.4±53.9	<0.05
Median difference	5 (−30–33)	−15 (−50–1)	<0.01
Total cholesterol (mg/dL)
Baseline	176.2±36.1	181.9±34.2	0.34
Follow-up	181.2±29.2	165.8±33.2	<0.01
Median difference	5 (−19–27)	−6 (−31–4)	<0.01

For normally distributed variables, the two-sample t-test is used and values are Means±SD. For nonnormally distributed variables, the two-sample Wilcoxon rank-sum (Mann–Whitney) test is used and values are Median (IQR). The difference between baseline and follow-up values has been expressed as the Median (IQR). IQR: Interquartile range, VLDL: Very LDL, HDL: High-density lipoprotein, LDL: Low-density lipoprotein, HbA1c: Glycated hemoglobin, SD: Standard deviation

Lifestyle habits and psychological health of the participants at baseline and end line

The effect on lifestyle habits, including dietary habits, physical activity patterns, and psychological, is summarized in Table 4. After 6 months of intervention, lower fat (49.94 ± 16.13 g vs. 56.26 ± 16.64 g, [P < 0.05]) and higher fiber intake (33.23 ± 8.43 g vs. 30.16 ± 7.8 g, [P < 0.05]) were reported in the follow-up assessment in the intervention group when compared to the control group. Although participants were counseled to follow an energy-deficit diet of approximately 500 kcal, the observed median change in energy intake was only 340 kcal. Significant median change was observed in the intervention group in energy intake (P < 0.01) and total fat consumption (P < 0.01). Furthermore, time spent in moderate-intensity activities after 6 months (19.97 min [IQR: 9.98, 31.37] vs. 9.99 min [IQR: 0, 19.97], [P < 0.01]) was significantly higher in the intervention group. Furthermore, statistically significant median differences were reported in baseline and follow-up assessment of time spent in moderate-intensity activities (P < 0.05) along with decreased time in leisure-related activities in the intervention group compared to the control group (−51.3 min [−101.23, 13.5] vs. −5.7 min [IQR: −74.14, 52.75], [P < 0.05]). There were significant improvements in psychological health as well with the median difference in Depression (−8 [−12, −2] vs. −4 [−8, 2] [P < 0.01]) and anxiety scores (−8 [−12, −2] vs. −2 [−8, 0], [P < 0.01]) at baseline and end line in the intervention group than the control group. The ITT analysis for anthropometric variables, biochemical parameters, and lifestyle-related parameters is presented in Supplementary Tables 2-4, respectively.

Table 4.

Lifestyle-related parameters, including dietary intake, physical activity, and psychological measurements at baseline and endpoint in the intervention group and the control group

Parameters	Control (n=63) Mean±SD/Median (IQR)	Intervention (n=71) Mean±SD/Median (IQR)	P
Nutrient intake
Energy (kcal)
Baseline	1606±391	1712±357	0.10
Endline	1443±274	1374±206	0.09
Median difference	−135 (−407–86)	−342 (−522–146)	<0.01
Protein (g)
Baseline	47.9±13.66	50.2±12.52	0.30
Follow-up	43.23±10.59	44.9±8.01	0.29
Median difference	−5.07 (−14.76–4.52)	−5.34 (−12.78–0.15)	0.59
Fat (g)
Baseline	61.68±23.73	70.27±25.69	0.04
Follow-up	56.26±16.64	49.94±16.13	<0.05
Median difference	−0.34 (−19.23–6.47)	−17.32 (−35.86–−6.09)	<0.01
Carbohydrates (g)
Baseline	208.9±60.21	212.15±57.3	0.75
Endline	185.8±38.8	180.6±33.5	0.41
Median difference	−20.6 (−64.6–14.9)	−39.63 (−66.4–3.94)	0.16
Fibre (g)
Baseline	32.7±11.06	32.57±11.36	0.94
Follow-up	30.16±7.8	33.23±8.43	<0.05
Median difference	0.09 (−10.25–6.18)	1.22 (−7.22–9.46)	0.24
Physical activity level
Time spent in work-related activities (min)
Baseline	0 (0-0)	0 (0-0)	0.46
Follow-up	0 (0-0)	0 (0-0)	0.26
Median difference	0 (0-0)	0 (0-0)	0.56
Time spent in general domain activities (min)
Baseline	788.3±145.04	823.61±149.13	0.16
Follow-up	797.9±160.11	777.85±138.4	0.43
Median difference	9.47 (−70.3–129.5)	−33.02 (144.7–57.75)	<0.05
Time spent in low-intensity activities (min)
Baseline	25.66 (9.98–39.92)	19.9 (8.55–29.94)	0.07
Follow-up	19.96 (12.83–29.94)	19.9 (9.98–29.94)	0.76
Median difference	0 (−18.5–14.97)	0 (−9.98–162.5)	14.97
Time spent in moderate-intensity activities (min)
Baseline	0 (0–19.97)	9.99 (0–19.97	0.49
Follow-up	9.99 (0–19.97)	19.97 (9.98–31.37)	<0.01
Median difference	0 (−4.99–19.97)	9.98 (0–21.39)	<0.05
Time spent in leisure related activities (min)
Baseline	200.3±84.76	219.7±97.53	0.22
Follow-up	185.99±86.40	174.28±95.94	0.46
Median difference	−5.7 (−74.14–52.75)	−51.3 (−101.23–13.5)	<0.05
Psychological parameter (DASS-score)
Depression
Baseline	16 (8–20)	18 (12–24)	<0.05
Follow-up	10 (6–18)	10 (6–16)	0.48
Median difference	−4(−8–2)	−8(−12–−2)	<0.01
Anxiety
Baseline	14 (10–20)	18 (14–22)	<0.01
Follow-up	10 (6–16)	10 (6–14)	0.68
Median difference	−2 (−8–0)	−8 (−12–−2)	<0.01
Stress
Baseline	16 (12–24)	20 (14–26)	0.12
Follow-up	12 (8–20)	12 (8–18)	0.59
Median difference	−4 (−10–2)	−6 (−12–0)	0.15

For normally distributed variables, the two-sample t-test is used and values are presented as is Mean±SD. For nonnormally distributed variables, the two-sample Wilcoxon rank-sum (Mann–Whitney) test is used and values are medians and IQRs. IQR: Interquartile range, SD: Standard deviation, DASS: Depression and Anxiety Scale-short

Supplementary Table 2.

Anthropometric and blood pressure outcome variables at baseline and endpoint in intervention and control groups (Intention-to-Treat Analysis [ITT])

Parameters	Control (n=80) Mean±SD/Median (IQR)	Intervention (n=80) Mean±SD/Median (IQR)	P
Weight (kg)
Baseline	70.61±9.74	71.17±8.96	0.71
Follow-up	70.07±9.92	67.94±8.45	0.15
Median difference	−0.75 (−1.55–0)	−3.2 (−4.35–−1.7)	<0.01
BMI (kg/m2)
Baseline	29.84±3.46	29.96±3.53	0.83
Follow-up	29.60±3.50	28.60±3.28	0.06
Median difference	−0.32 (−0.67–0)	−1.33 (−1.83–−0.68)	<0.01
WC (cm)
Baseline	94.54±8.33	94.59±8.68	0.96
Follow-up	93.77±8.75	90.83±7.91	0.02
Median difference	−1.25 (−2.2–0)	−3.25 (−4.7–−1.75)	<0.01
WHR
Baseline	0.93±0.06	0.95±0.07	0.25
Follow-up	0.94±0.06	0.94±0.08	0.74
Median difference	0.0005 (−0.0015–0.0074)	−0.0004 (−0.0147–0.0073)	<0.01
Body composition
Muscle mass (kg)
Baseline	22.21±2.82	22.35±2.48	0.73
Follow-up	22.72±3.24	22.75±2.61	0.96
Median difference	0.1 (0–0.85)	0.2 (−0.2–0.9)	0.99
Body fat percentage (%)
Baseline	43.19±5.14	43.44±5.30	0.76
Follow-up	42.29±5.34	41.29±4.95	0.22
Median difference	−0.35 (−1.7–0)	−2.2 (−3.2–1)	<0.01
Blood pressure
Systolic blood pressure (mmHg)
Baseline	131.72±18.44	133.02±14.96	0.62
Follow-up	130.33±16.94	126.51±13.15	0.11
Median difference	−2 (−7–1)	−5 (−9–0)	<0.01
Diastolic blood pressure (mmHg)
Baseline	83.49±11.18	83.52±7.69	0.98
Follow-up	81.51±9.49	80.48±7.63	0.45
Median difference	−0.5 (−5.5–1.5)	−3 (−6–1)	0.32

For normally distributed variables, the two-sample t-test is used and values are means±SD. For nonnormally distributed variables, the two-sample Wilcoxon rank-sum (Mann–Whitney) test is used and values are medians and IQR. SD: Standard deviation, WC: Waist circumference, WHR: Waist-to-hip ratio, BMI: Body mass index, IQR: Interquartile range, IQR: Interquartile Range (P25–P75)

Supplementary Table 4.

Lifestyle-related parameters, including dietary intake, physical activity, and psychological measurements at baseline and endpoint in the intervention and control groups (Intention-to-Treat Analysis [ITT])

Parameters	Control (n=80) Mean±SD/Median (IQR)	Intervention (n=80) Mean±SD/Median (IQR)	P
Nutrient intake
Energy (kcal)
Baseline	1609±372	1720±368	0.06
Endline	1481±287	1418±275	0.16
Median difference	0 (−296–30)	−300 (−491–103)	<0.001
Protein (g)
Baseline	48.39±13.25	50.69±13.38	0.27
Follow-up	44.67±11.14	45.93±10.19	0.46
Median difference	0 (−11.39–2.66)	−4.02 (−11.58–0)	0.2
Fat (g)
Baseline	62.64±24.41	69.14±25.19	0.09
Follow-up	58.37±19.61	51.09±16.74	<0.01
Median difference	0 (−11.65–5.04)	−15.30 (−31.52–−0.08)	<0.001
Carbohydrates (g)
Baseline	207.95±57.64	211.53±60.7	0.70
Endline	189.73±41.42	183.6±42.8	0.35
Median difference	−1.28 (−41.08–4.13)	−31.9 (−61.58–1.51)	0.08
Fiber (g)
Baseline	31.95±10.79	32.43±11.10	0.78
Follow-up	29.83±8.07	33.01±8.48	<0.05
Median difference	0 (−5.97–4.34)	0 (−6.49–6.96)	0.3
Physical activity level
Time spent in work-related activities (min)
Baseline	0 (0–0)	0 (0–0)	0.22
Follow-up	0 (0–0)	0 (0–0)	0.60
Median difference	0 (0–0)	0 (0–0)	0.60
Time spent in general domain activities (min)
Baseline	776.17±139.73	831.09±160.49	<0.05
Follow-up	783.69±152.75	790.48±154.42	0.78
Median difference	0 (−57.08–74.38)	−25.38 (−130.28–22.04)	<0.01
Time spent in low-intensity activities (min)
Baseline	19.96 (9.98–32.08)	18.53 (8.55–29.9)	0.07
Follow-up	19.96 (9.98–29.94)	19.96 (9.98–29.94)	0.75
Median difference	0 (−8.55–9.98)	0 (−6.42–10.69)	0.42
Time spent in moderate-intensity activities (min)
Baseline	0 (0–19.97)	9.98 (0–19.97)	0.81
Follow-up	9.98 (0–21.03)	19.97 (8.56–29.96)	<0.01
Median difference	0 (0–9.98)	9.98 (0–19.97)	<0.01
Time spent in leisure related activities (min)
Baseline	202.57±92.13	217.09±96.16	0.33
Follow-up	191.26±93.76	176.79±94.71	0.33
Median difference	0 (−48.12–25.66)	−42.77 (−98.38–4.28)	<0.05
Psychological parameter (DASS-score)
Depression
Baseline	16 (10–22)	18 (12–24)	0.13
Follow-up	12 (6–19)	10 (6–18)	0.18
Median difference	0 (−7–0)	−6 (−12–0)	<0.01
Anxiety
Baseline	16 (10–22)	18 (14–24)	<0.05
Follow-up	12 (6–18	10 (6–16)	0.28
Median difference	−1 (−6–0)	−6 (−12–0)	<0.01
Stress
Baseline	18 (12–25)	22 (14–27)	0.19
Follow-up	14 (8–22)	14 (8–20)	0.41
Median difference	−2 (−6–0)	−5 (−12–0)	0.08

For normally distributed variables, the two-sample t-test is used and values are means±SD. For nonnormally distributed variables, the two-sample Wilcoxon rank-sum (Mann–Whitney) test is used and values are medians and IQR. SD: Standard deviation, IQR: Interquartile range, DASS: Depression and anxiety scale-short version, IQR: Interquartile Range (P25–P75)

Supplementary Table 3.

Biochemical parameters at baseline and endpoint in the intervention and control groups (Intention-to-Treat Analysis [ITT])

Parameters	Control (n=80) Mean±SD/Median (IQR)	Intervention (n=80) Mean±SD/Median (IQR)	P
Biochemical parameters
Fasting blood glucose (mg/dL)
Baseline	100.90±29.21	109.4±42.67	0.14
Follow-up	101.83±33.00	103.37±39.31	0.79
Median difference	0 (−5.15–3.75)	−1.4 (−11.3–4.1)	0.10
HbA1c (%)
Baseline	6.17±1.21	6.21±1.34	0.85
Follow-up	6.21±1.16	6.05±1.14	0.37
Median difference	0 (−0.11–0.17)	−0.105 (−0.3–0.08)	<0.01
LDL (mg/dL)
Baseline	102.31±30.582	102.21±32.64	0.98
Follow-up	103.42±27.77	95.08±28.59	0.06
Median difference	0 (−8–13.5)	−2 (−17.5–3)	<0.05
HDL (mg/dL)
Baseline	46.57±10.63	46.2±9.69	0.82
Follow-up	49.18±10.98	46.22±9.74	0.07
Median difference	1 (−0.5–7)	0 (−5–5.5)	<0.05
VLDL (mg/dL)
Baseline	29.86±11.02	32.18±13.70	0.24
Follow-up	30.39±10.76	27.15±10.53	<0.05
Median difference	0 (−2.5–5.5)	−3 (−8–0)	<0.01
Triglycerides (mg/dL)
Baseline	151.16±53.70	157.6±62.90	0.49
Follow-up	152.82±52.86	134.95±52.78	<0.05
Median difference	0 (−14.5–23.5)	−13.5 (−43–0)	<0.01
Total cholesterol (mg/dL)
Baseline	179.51±36.23	181.86±34.79	0.67
Follow-up	183.47±30.55	167.48±34.18	<0.01
Median difference	0 (−13.5–20.5)	−5 (−27–1)	<0.01

For normally distributed variables, the two-sample t-test is used and values are means±SD. For nonnormally distributed variables, the two-sample Wilcoxon rank-sum (Mann–Whitney) test is used and values are medians and ranges. The difference between baseline and follow-up values has been expressed as median and IQR. LDL: Low-density lipoprotein, HDL: High-density lipoprotein, VLDL: Very low-density lipoprotein, HbA1c: Glycated hemoglobin, SD: Standard deviation, IQR: Interquartile range, IQR: Interquartile Range (P25–P75)

Weight loss after 6 months of follow-up

After a 6-month intervention, 34 women achieved a weight reduction of <5%, while 30 experienced a weight loss ranging from 5% to 10% [Table 5]. In addition, four women achieved weight reduction exceeding 10% of their baseline body weight, and three women gained weight during the period. Contrastingly, in the control group, 46 perimenopausal women lost <5% of their baseline body weight. Furthermore, two women in the control group exhibited weight loss exceeding 5%. Meanwhile, 15 women in the control group experienced weight gain throughout the follow-up period.

Table 5.

Frequency of significant weight loss outcomes in intervention and control group

Weight percentage	Control (n=80)	Intervention (n=80)
<2.5	30 (37.5)	11 (13.75)
2.5–5	16 (20.0)	23 (28.75)
5–10	2 (2.5)	30 (37.50)
More than 10	0	4 (5.00)
Weight gain	15 (18.75)	3 (3.75)
Dropout	17 (21.25)	9 (11.25)

Values are frequency and percentage with Fisher’s exact value P<0.01

DISCUSSION

Weight management during the menopausal transition is an effective strategy to prevent obesity and associated metabolic diseases and improve overall health and, thus, quality of life.[20] The present study enumerated various noteworthy findings about the effectiveness of an individualized comprehensive weight management program for perimenopausal women.

The intervention arm exhibited statistically significant differences in median weight change, BMI, WC, and WHR after undergoing the individualized comprehensive lifestyle intervention, which is similar to a meta-analysis reporting mean weight loss ranging from 9.51 kg to 3.59 kg with the use of different diet-related and physical activity-based interventions across studies.[21] The reductions in WC and WHR with this intervention were also consistent with the results from a study by Wu et al. reporting similar reductions in the WHR, blood pressure, and biochemical parameters in the intervention group.[22]

Across studies, it has been well established that women during these transitional years tend to have changes in body composition, especially fat redistribution and loss of muscle mass.[23,24] After 6 months of lifestyle modification, the intervention group had a significant reduction in body fat percentage, echoing the findings of Englert et al., who reported significant reductions in fat-free mass (−1.1 ± 1.2 kg, P < 0.001) following a 12-week intervention.[25] However, no significant difference was seen in lean mass across the groups. Furthermore, significant improvements were observed in biochemical parameters. While findings from a randomized trial in China reported a significant decrease in total cholesterol (−0.07 vs. 0.03 mmol/L, P < 0.05) and LDL cholesterol (−0.13 vs. 0.01 mmol/L, P = 0.05) in the intervention group.[22] With overall improvement across various metabolic markers, the intervention reduced the risk of metabolic diseases, balancing the effect of menopause, the predominant risk factor, predisposing menopausal women to cardiovascular diseases. Thus, timely implementation of such interventions aiming at lifestyle modification and sustainable weight loss can be an effective and preventive public health strategy to reduce the burden of such diseases.

Dietary modifications including energy-restricted diets rich in complex carbohydrates, low in fat, and high in protein, form the cornerstone of successful weight loss interventions along with additional benefits such as prevention and management of metabolic diseases and menopausal symptoms.[26] The present study also reported similar observations. Women in the intervention arm consumed lower calories and significantly reduced fat and increased fiber in their diets, promoting weight loss and managing metabolic diseases and menopausal symptoms. Besides improved dietary habits, women in the intervention arm spent significantly more time in moderate-intensity activities with a reduction in leisure time sedentary activities. Thus further facilitating sustainable weight loss and improved physical, metabolic, and psychological health.[27,28]

The inclusion of healthy eating habits and a physically active lifestyle not only helped the participants with improved anthropometric and metabolic markers, but they also showcased improved psychological health. Psychological disturbances such as mood swings, anxiety, and depression are commonly experienced during these years.[29] Poor psychological health has also been directly correlated with unhealthy lifestyle such as stress eating, physical inactivity, and disturbed sleep, thus further favoring weight gain.[30] On the other hand, inclusion of healthy lifestyle habits has been associated with improved psychological well-being. Similarly, the present study reported better psychological health in the intervention arm than the control, with an improved median change in depression and anxiety scores. A similar improvement in psychological health has been noted in a weight loss intervention study conducted by Imayama et al., 2011 on menopausal women focusing on exercise and quality of life.[31]

Overall, this study emphasized the role of individualized comprehensive lifestyle intervention for weight management among perimenopausal women. Incorporating behavioural modification strategies such as self-monitoring, stimulus control, problem-solving, motivation, and maintenance can facilitate healthy and sustainable weight loss, while also reducing the risk of weight regain.

Strengths and limitations

This interventional study evaluating the efficacy of an individualized comprehensive weight management program for perimenopausal women demonstrates several strengths. It has a rigorous methodology providing robust evidence for the effectiveness of the intervention. The study comprehensively evaluates demographic, lifestyle-related, menopausal and cultural factors influencing weight management during the transition and implements a tailored approach to address them effectively. However, the study also has a few limitations, including a relatively short follow-up and self-reporting of lifestyle-related data, especially dietary and physical activity recall and psychological health. Future research could mitigate these limitations by extending follow-up duration and implementing strategies to improve participant retention and compliance.

Further directions

The inclusion of comprehensive weight management intervention can serve as a model for future interventions targeting similar populations, offering a roadmap for healthcare providers to optimize strategies for menopausal weight management addressing obesity-associated metabolic morbidities and improving quality of life. Furthermore, future research should address the limitations by extending follow-up duration, implementing strategies to enhance participant retention and compliance, and exploring additional outcome measures such as metabolic markers and quality-of-life indicators.

CONCLUSION

This study evaluating the efficacy of an individualized comprehensive weight management module for perimenopausal women provides valuable insights into addressing unique weight management challenges within this demographic. Results from the study indicate that the developed module significantly contributes to achieving reductions in anthropometric parameters, improvements in biochemical parameters, and psychological well-being, as well as the adoption of healthy lifestyle habits. These findings support the effectiveness of tailored and intensive counseling strategies for achieving significant weight loss outcomes through the incorporation of sustainable lifestyle changes, such as calorie-restricted, nutrient-rich diet and gradual physical activity, promoting meaningful and holistic health improvements during the menopausal transition.

Availability of data and materials

The datasets generated or analyzed during the current study are available from the corresponding author on reasonable request.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

The study was supported by the SEED Division, Department of Science and Technology, Government of India.