Table 2.

Treatment after a Very-Low-Calorie-Diet

Medication Use
Study	N	Treatment	Length of WM Tx	Results	% Weight Change	Effect Size
Richelsen et al⁴¹	309 (157 women) 200 at end of trial 35% attrition Ethnicity not reported	2-GROUP DESIGN: Orlistat 120mg TID Placebo Both groups were prescribed a reduced calorie diet (−600 kcal/d); visits with dietary and lifestyle counseling every mo for 18 mo then every 3 mo thereafter	3-year WM after 8- week VLCD	During WM ^a: Orlistat +4.6 ± 8.6kg Placebo +7.0 ± 7.1kg p < .02 for group differences	After 3 years: Men Orlistat: −8.3% Placebo: −7.5%, p = NS Women Orlistat: −8.4% Placebo: −5.3%, p < .02	.13
Laaksonen et al³⁹	41 (20 women) 34 at end of trial 17% attrition Ethnicity not reported	2-GROUP DESIGN: Orlistat 120mg TID Placebo Both followed a reduced- calorie and fat diet of at least 1200 kcal/d personalized according to estimated energy expenditure	1-year WM after 9- week VLCD	Prior to WL Rx through WM ^a: −12.6 ± 7.4 kg for entire sample with no difference between groups, p- value not reported	Those who lost ≥ 10% ^a: Weight change in the last 6 months was +0.6 ± 2.3 kg	Unable to determine from data provided.
LeCheminant et al⁴⁰	147 (107 women) 92 at end of trial 41% attrition Ethnicity not reported	2-GROUP DESIGN: 2 meal replacements daily + meal plan Orlistat 120 mg BID + meal plan In both groups the meal plan was to maintain weight; weekly group meetings in lifestyle modification until 26 weeks then biweekly thereafter.	36-week WM after 12-week VLCD & 4 weeks of solid foods	Weight after WL ^a: Meal replacements 85.4 ± 14.3 kg Orlistat 120 mg 85.7 ± 17.9 kg Weight after WM ^a: Meal replacements 88.1 ± 16.5 kg Orlistat 120 mg 88.5 ± 20.3 kg	During WM: Men 4.9% increase in body weight, p < .05 Women 2.4% increase in body weight, p = NS	.02
Mathus-Vliegen et al⁴⁴	189 (162 women) 119 at end of trial 37% attrition >98% White	2-GROUP DESIGN: Sibutramine 10mg/d- could increase to 15 mg after 6 mo if weight gain of > 3 kg Placebo Both groups had biweekly meetings with GP and dietitian for 2 mo, monthly until 12 mo & bi-monthly thereafter; 600 calorie- deficit/d	18-month WM after 10-week VLCD & 2 weeks of including solid foods	Prior to WL Rx through WM ^a: Sibutramine −10.7 ± 0.5 kg or −10.3 ± 7.0% Placebo −8.5 ± 8.1 kg or −7.9 ± 7.3%	During WM: Sibutramine +4.1 kg or 4.5% Placebo +6.7 kg or 7.6% p = .004 for between group differences	.21
Apfelbaum et al⁴³	160 (127 women) 108 at end of trial 32% attrition Ethnicity not reported	2-GROUP DESIGN: Sibutramine 10mg/d Placebo Both groups had dietary counseling to consume 20– 30% less total calories than pre-weight loss intake; individual meeting with dietician every 3 months; assessments monthly	1-year WM after 4-week VLCD	During WM ^a: Sibutramine 10mg/d −5.2 ± 7.5 kg Placebo +0.5 ± 5.7 kg p = .004 for group differences	Sibutramine 75% of group sustained ≥ 100% of lost weight Placebo 42% of group sustained ≥ 100% of lost weight p = .004 for group differences	.23
Hauner et al⁴⁶	110 (84 women) 75 at end of trial 29% attrition 100% White	2-GROUP DESIGN: Acarbose 50–300 mg/d titrated weekly; 59.3% of group took 300 mg Placebo Both groups were advised to follow a personalized WM diet	26-week WM after 12-week VLCD	During WM: Acarbose no weight gain Placebo +0.6 kg p = .38 for group differences	Acarbose No weight change Placebo 6% regain of lost weight	.09
Wadden et al⁴⁷	53 (all women) 30 at end of trial 43% attrition Ethnicity not reported	2-GROUP DESIGN: Sertraline 200mg/d Placebo Both groups received a relapse prevention training program in weekly group meetings for 4 weeks & biweekly for 50 weeks	54-week WM after 26-week WL Rx with VLCD and behavior therapy	During WM ^a: Sertraline +17.7 ± 10.6 kg regained of the 26.3 ± 7.6 kg original loss Placebo +11.8 ± 9.0 kg regained of the 23.4 ± 7.8 kg original loss p = NS for between group differences	Sertraline 70.9 ± 41.7%^a of lost weight regained Placebo 46.5 ± 34.6%^a of lost weight regained	.60
Dietary, Macronutrient, and Other Supplementation
Toubro & Astrup⁴⁸	43 (39 women) 37 eligible for WM 34 at end of trial 21% attrition Ethnicity not reported	2-GROUP DESIGN: Ad lib 55% carb, 20–25% fat diet; 24-pg dietary booklet Reduced-calorie 7.8 MJ/d (1875 kcal) using 144 color-coded cards to represent foods, each card = 65.2 kcal Both groups had 2–3 group meetings a month for 6 mo, then monthly	1-year WM after 8 weeks VLCD with 1 year follow-up	During WM: Ad lib +0.3 (95% CI, −3.0 to 3.6) kg regained Reduced-calorie +4.1 (95% CI, 1.2 to 6.9) kg regained p = .08 for a group difference	After 1 yr f/u: Ad lib +5.4 (95% CI, 2.3 to 8.6) kg of initial 13.5 kg WL regained (40%) Reduced-calorie +11.3 (95% CI, 7.1 to 15.5) kg of initial 13.8 kg WL regained (82%) p = .03 for a group difference	.29
Pasman et al⁵³	39 (all women) 31 at end of trial 20% attrition Ethnicity not reported	2-GROUP DESIGN: Fiber 10 mg BID 10 g guar gum BID Control Both groups had no dietary restrictions or physical activity advise; assessments at 2, 8 & 14 months with 3-day food diaries of food intake	14-month WM after 2-month VLCD	During WM ^a: Group A (consumed > 80% of fiber) +65 ± 65% regain of lost weight Group B (consumed 50–80% of fiber) +123 ± 63% regain of lost weight Control +61 ± 66% regain of lost weight	Group A 6/10 persons regained ≥ 50% Group B 9/10 persons regained ≥ 50% Control 7/11 persons regained ≥ 50%	.33
Pasman et al⁵⁴	39 (all women) 33 at end of trial 15% attrition Ethnicity not reported	3-GROUP DESIGN: 50 g carbohydrate + 200 μg chromium-picolinate + 20 g fiber + 100 mg caffeine (CHO+) 50 g carbohydrate (CHO) Control Both groups followed an ad lib diet; assessments at 4, 10 & 16 mo with 3-day food diaries of food intake	16-month WM after 2- month VLCD	During WM ^a: (CHO+) 51.1 ± 109.0% regain of lost weight (CHO) 68.1 ± 55.2% regain of lost weight Control 85.5 ± 55.8% regain of lost weight	(CHO+) 31% regained < 50% of lost weight (CHO) 36% regained < 50% of lost weight Control 21% regained < 50% of lost weight	CHO+ vs. Control = .40 Control vs. CHO = .31 CHO+ vs. CHO = .20
Kovacs et al⁴⁹	104 (78 women) 104 at end of trial No attrition Ethnicity not reported	2-GROUP DESIGN: Green tea 450 mg/d 2 capsules with each meal Placebo No dietary or activity instructions specified	13-week WM after 4-week VLCD	During WM ^a: Green tea 450 mg/d 30.5 ± 61.8% regain of lost weight Placebo 19.7 ± 56.9% regain of lost weight p = NS for group differences	High-caffeine consumer who received green tea +39 ± 17%^a Low-caffeine consumer who received green tea +16 ± 11%^a p < .05 for group differences	.18
Westerterp- Plantenga et al⁵⁰	76 (53 women) 76 at end of trial No attrition Ethnicity not reported	2-GROUP DESIGN: Green tea-caffeine mix (150 mg caffeine/d) 2 capsules with each meal Placebo Randomized after stratification for high caffeine (HC) intake (> 300 mg/d) and low caffeine (LC) intake (< 300 mg/d); food intake not assessed	3-month WM after 4-week WL	During WM: Weight loss continued in the green-tea group with low caffeine intake and increased in both the placebo group with low caffeine intake as well as the green-tea group with high caffeine intake, p < .01 for group differences.	Green tea + LC −11.1 ± 24.3%^a weight loss Placebo + LC +40.8 ± 38.9%^a weight regain Green tea + HC +24.4 ± 18.7%^a weight regain	.30
Westerterp- Plantenga et al⁵²	148 (“women & men”) 148 at end of trial No attrition Ethnicity not reported	2-GROUP DESIGN: Added protein 48.2 g/d as 2 drinks Control Both groups followed an ad lib diet, counseling as needed from dietician	3-month WM after 4-week VLCD	During WM ^a: Added protein 17.3 ± 60.3% regain of lost weight Control 36.6 ± 46.8% regain of lost weight p < .05 for group differences	50% less weight regained in added protein group compared to control	.16
Lejeune et al⁵¹	120 (“women & men”) 113 at end of trial 6% attrition Ethnicity not reported	2-GROUP DESIGN: Added protein 30 g/d as 1 drink Control Both groups had monthly visits for 6 mo; allowed to eat usual diet; counseling as requested from dietician	6-month WM after 4-week VLCD	During WM ^a: Added protein 19.6 ± 82.1% regain of lost weight Control 54.9 ± 65.8% regain of lost weight p < .05 for group differences	Net weight loss after WM compared to pre- VLCD: Added protein −6.7 ± 7.2%^a Control −3.8 ± 4.8%^a p < .05 for group differences	.18
VLCD Use
Ryttig et al⁵⁷	81 (44 women) 76 eligible for WM 42 at end of trial 45% attrition Ethnicity not reported	3-GROUP DESIGN: 1600 kcal/d diet for WL & WM (A) 1600 kcal/d diet with 239 kcal of VLCD in WM (B) 1600 kcal/d diet in WM (C) All were instructed to maintain same level of physical activity; monthly assessments for 7 months then every 7 weeks	24-month WM after 2-month VLCD or 1600 kcal/d diet	Prior to WL Rx to trial end ^a: −10.9 ± 10.2 kg in all groups Weight at end of Rx ^a: Group A 110.7 ± 17.4 kg Group B 107.3 ± 15.1 kg Group C 107.5 ± 16.9 kg NS group differences	Group A −7% overall Group B −10% overall Group C −9.5% overall	A vs. B = .21 A vs. C = .19 B vs. C = .01
Lantz et al⁵⁶	334 (248 women) 117 at end of trial 65% attrition Ethnicity not reported	3-GROUP DESIGN: Intermittent VLCD Repeat VLCD for 2 weeks every 3^rd month On-demand VLCD Use VLCD when weight surpasses 3 kg above weight after VLCD Both had appointments biweekly for 6 months then monthly thereafter	2-year WM after 16- week VLCD	Prior to WL Rx to trial end ^a: Intermittent VLCD -6.2 ± 9.5% On-demand VLCD −7.7 ± 8.4% p < 0.001 for significant loss over time; p = NS for group differences	Intermittent VLCD 44% maintained a ≥ 5% weight loss On-demand VLCD 62% maintained a ≥ 5% weight loss	.17
Agras et al⁵⁵	194 (all women) 174 at end of trial 10% attrition Ethnicity not reported	4-GROUP DESIGN: Standard food + time dependent (S + T) Regular food started 1 meal at a time at set intervals over 4 weeks Standard food + weight dependent (S + W) Regular food started only when weight stable over 1– 3 months Prepackaged food + time dependent (P + T) Prepackaged meals started 1 meal at a time at set intervals over 4 weeks Prepackaged food + weight dependent (P + W) Prepackaged meals started only when weight stable over 1–3 months All received group behavior therapy in weekly meetings for 3 months, biweekly meetings for 3 months and monthly thereafter	9-month WM after 12-week VLCD with follow up 9 months after WM	Prior to WL Rx to trial end ^a: S + T −8.2 ± 12.3 kg S + W −8.6 ± 11.4 kg P + T −6.0 ± 11.1 kg P + W −2.8 ± 18.3 kg p = NS for group differences	No significant differences in percent weight regain among the 4 groups after VLCD.	S+T vs. S+W = .03 S+T vs. P+T = .19 S+T vs. P+W = .35 S+W vs. P+T = .23 S+W vs. P+W = .38 P+T vs. P+W = .21
Physical Activity
Fogelholm et al⁵⁹	82 (all women) 80 at end of trial 2% attrition Ethnicity not reported	3-GROUP DESIGN: Walk 1 Use 1000 kcal/week walking Walk 2 Use 2000 kcal/week walking Control No walking program All receive a low-fat diet, weekly group meetings, monthly materials on a healthy diet, pedometers	40-week WM after 12-week VLCD	During WM ^b: Walk 1 −0.7 (1.0) kg Walk 2 +0.2 (0.9) kg Control +1.7 (0.8) kg p = .18 for group differences	Not reported	.15
Borg et al⁵⁸	90 (all men) 82 at end of trial 9% attrition Ethnicity not reported	3-GROUP DESIGN: Walking 45-min sessions 3 times/week Resistance training 45-min sessions 3 times/week Control No increase in activity All received a low-fat, ad-lib diet, weekly group meetings, food and exercise diaries	6-month WM after 2-month VLCD with 23- month follow up	During WM adjusted mean difference to control: Walking +0.3 kg (95% CI, −2.2 to 2.8) Resistance training −1.3 kg (95% CI, −3.8 to 1.1) p = .25 for group differences	At 23-month follow-up: 47.5% of all participants regained > 10% compared to weight after WL Rx	.13

Abbreviations: CI, confidence interval; GP, general practitioner; NS, non-significant; Tx, treatment; VLCD, very-low-calorie diet; WL, weight loss; WM, weight maintenance.

mean ± standard deviation.

mean ± stand error of the mean.