Bales 2017.

Study characteristics
Methods	Review comparison(s) addressed by this study: 1 Study design: RCT, parallel, single‐centre (1) Trial registry number: NCT02033655 Total number of trial arms: 2 Year trial started: 2014 Sample size calculation: no Outcome(s) used for sample size calculation: NA Duration of run‐in period (weeks): NA What was the duration of the weight loss phase: 6 months What was the duration of the weight maintenance phase: NA Other notes about methods: NA
Participants	Country and setting: USA, outpatient university medical centre in Durham Eligibility criteria: Participants were women aged ≥ 45 years with BMI ≥ 30 kg/m2. Participants were excluded if they suffered from dementia; had a functional limitation caused by a neurological condition; unstable or terminal medical conditions or a glomerular filtration rate decrease of ≥ 10% or < 45 mL/min/1.73 m². Type 2 diabetes at baseline: Unclear Impaired glucose tolerance at baseline: Unclear Cardiovascular conditions/risk factors/events at baseline: Unclear Gender: Female Total number randomised: 80 Total attrition in trial: 38 Treatment diet Participants randomised: 51 Participants withdrawn (voluntary): NR Total attrition: 22 Control diet: Participants randomised: 29 Participants withdrawn (voluntary): NR Total attrition: 16 Baseline data treatment diet: Randomised participants not included: None Age (years): mean (SD) 58.9 (8.4), range 45.0 to 78.0 Gender distribution (as reported): female 100%, male 0% Weight (kg): mean (SD) 98.6 (18.6) BMI (kg/m2): mean (SD) 37.5 (6.1) DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): NR HDL (mmol/L): NR Non‐HDL (mmol/L): NR TC (mmol/L): NR TG (mmol/L): NR Baseline data control diet: Randomised participants not included: None Age (years): mean (SD) 61.8 (7.6), range 46.0 to 73.0 Gender distribution (as reported): female 100%, male 0% Weight (kg): mean (SD) 103.0 (15.6) BMI (kg/m2): mean (SD) 38.3 (5.8) DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): NR HDL (mmol/L): NR Non‐HDL (mmol/L): NR TC (mmol/L): NR TG (mmol/L): NR Group differences at baseline: Characteristic(s) with significant group difference and relevant statistic: NA Other notes about participants: NA
Interventions	Energy (E) comparison of treatment vs control diets: Similar energy prescription/approach to restrict energy intake in both diets Treatment diet: Name (as reported) and brief description: High‐protein weight loss (HP‐WL) diet prescribing 1.2 g/kg body weight of protein with a target of 30 g protein/meal and a distribution of ~30% protein, 30% fat and 40% carbohydrates. Energy intake ~500 kcal below calculated requirement Treatment diet type (carbohydrate‐fat‐protein): Low‐balanced‐high Exercise component? No Recipients: N = 51 women, mean (SD) age 58.9 (8.4) and range 45.0–78.0 years, mean (SD) weight 98.6 (18.6) kg, mean (SD) BMI 37.5 (6.1) kg/m2 and mean (SD) fasting blood glucose 111.7 (40.9) mg/dL Why? To evaluate the effects of a high protein diet with balanced protein distribution on lean muscle mass for weight loss and preserving physical function What (materials)? "Participants received individualized kilocalorie prescription and meal plans. To promote achievement of the protein intake target, participants were supplied with preportioned frozen or chilled lean meats (lean ground pork, pork tenderloins, pork chops, and low‐sodium ham) sufficient to provide $420 g protein/wk ($30 g for 2 meals/d) for the duration of the trial." What (procedures)? HP‐WL participants were prescribed a protein intake of 1.2 g/kg body weight, with a target of 30 g protein/meal and a distribution of 30% protein, 30% fat, and 40% carbohydrates. Because high‐quality protein is superior for promoting anabolism (29, 30), the HP‐WL meal plan emphasised protein from animal sources, primarily lean meats and poultry, low‐fat dairy, fish, and eggs. To avoid monotony and allow flexibility, participants consumed other complete proteins (e.g. other lean meats, poultry and fish, low‐fat dairy foods, and eggs) at the third meal of each day according to their prescribed meal plan. All of the participants were prescribed an energy intake; 500 kcal below their calculated requirement, as derived from calculations of estimated total energy expenditure on the basis of weight, height, sex, age, and activity level with the use of published equations. Meetings with the dietitian (individual and group) with diet plans provided and assessments of nutrient intakes made per protocol Who provided? "Registered dietitians who were experienced in obesity treatment..." How and where? Face‐to‐face at Duke University Medical Center facilities When and how much? "After the 2 individual sessions, participants attended weekly group meetings (specific to study group but equivalent in structure and duration) for diet and health‐related counseling, peer support, and weekly weigh‐ins." Strategies to improve or maintain fidelity; tailoring and modification: "Interventionists reviewed participants’ daily food journals each week and adjusted their menus to ensure that the target kilocalorie intake and, for the HP‐WL group, 30 g protein/meal for breakfast, lunch, and dinner were regularly achieved, as previously described." Weigh‐ins and group meetings were also conducted. Extent of intervention fidelity: Weekly sessions and assessments. To promote achievement of the protein intake target, participants were supplied with preportioned frozen or chilled lean meats during the whole trial. Concomitant interventions: "All participants were supplied with a low‐dose multivitamin supplement (GNC Teen Multivitamin), along with 400 mg Ca and 600 IU vitamin D (Bayer Citracal Calcium Supplement +D3) to ensure adequate nutrient intake and to standardize supplement use (participants were instructed to discontinue all other nutritional supplements)." Control diet: Name (as reported) and brief description: Control weight loss (C‐WL) diet prescribing RDA for protein of 0.8 g/kg body weight with a distribution of calories of ~15% protein, 30% fat and 55% carbohydrates. Energy intake ~500 kcal below calculated requirement Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐balanced Exercise component? No Recipients: N = 29 women, mean (SD) age 61.8 (7.6) and range 46.0–73.0 years, mean (SD) weight 103.0 (15.6) kg, mean (SD) BMI 38.3 (5.8) kg/m2 and mean (SD) fasting blood glucose 106.9 (31.2) mg/dL Why? NR What (materials)? "Participants received individualized kilocalorie prescription and meal plans." What (procedures)? The C‐WL group was prescribed the RDA for protein of 0.8 g/kg body weight, with a distribution of calories of 15% protein, 30% fat, and 55% carbohydrates. All of the participants were prescribed an energy intake 500 kcal below their calculated requirement, as derived from calculations of estimated total energy expenditure on the basis of weight, height, sex, age, and activity level with the use of published equations. Meetings with the dietitian (individual and group) with diet plans provided and assessments of nutrient intakes made per protocol Who provided? "Registered dietitians who were experienced in obesity treatment..." How and where? Face‐to‐face at Duke University Medical Center facilities When and how much? "After the 2 individual sessions, participants attended weekly group meetings (specific to study group but equivalent in structure and duration) for diet and health‐related counseling, peer support, and weekly weigh‐ins." Strategies to improve or maintain fidelity; tailoring and modification: "Interventionists reviewed participants’ daily food journals each week and adjusted their menus to ensure that the target kilocalorie intake and, for the HP‐WL group, 30 g protein/meal for breakfast, lunch, and dinner were regularly achieved, as previously described." Weigh‐ins and group meetings were also conducted. Extent of intervention fidelity: Weekly sessions and assessments. To promote achievement of the protein intake target, participants were supplied with preportioned frozen or chilled lean meats during the whole trial. Concomitant interventions: "All participants were supplied with a low‐dose multivitamin supplement (GNC Teen Multivitamin), along with 400 mg Ca and 600 IU vitamin D (Bayer Citracal Calcium Supplement +D3) to ensure adequate nutrient intake and to standardize supplement use (participants were instructed to discontinue all other nutritional supplements)."
Outcomes	Change in body weight (kg) at 3 to < 12 months: Yes Change in body weight (kg) at ≥ 12 months: No Number of participants with 5% weight loss from baseline at 3 to < 12 months: No Number of participants with 5% weight loss from baseline at ≥ 12 months: No Change in BMI (kg/m2) at 3 to 12 months: No Change in BMI (kg/m2) at ≥ 12 months: No Number of participants with 5% BMI reduction from baseline at 3 to 12 months: No Number of participants with 5% BMI reduction from baseline at ≥ 12 months: No Change in DBP (mmHg) at ≥ 12 months: No Change in SBP (mmHg) at ≥ 12 months: No All‐cause mortality at ≥ 12 months: No Cardiovascular mortality at ≥ 12 months: No Non‐fatal myocardial infarction at ≥ 12 months: No Non‐fatal stroke at ≥ 12 months: No Diagnosis of type 2 diabetes mellitus at ≥ 12 months: No Change in HbA1c (%) at ≥ 12 months: No Change in LDL (mmol/L) at ≥ 12 months: No Change in HDL (mmol/L) at ≥ 12 months: No Change in non‐HDL (mmom/L) at ≥ 12 months: No Change in total cholesterol (TC) (mmol/L) at ≥ 12 months: No Change in triglycerides (or triacylglycerides) (TG) (mmol/L) at ≥ 12 months: No Participant‐reported adverse effects: No
Notes	Number and type of records(s): journal article Trial acronym/name: POWR‐UP Trial funded by: Pork Checkoff Program, North Carolina Pork Council, Smithfield Foods and the NIH (grants 5T32 AG000029, 1P30 AG028716 and K12 HD043446) Declaration of interest: "Author disclosures: CW Bales, KN Porter Starr, MC Orenduff, SR McDonald, K Molnar, AK Jarman, A Onyenwoke, H Mulder, ME Payne, and CF Pieper, no conflicts of interest. The sponsors had no influence on the protocol design, conduct of the trial, or data analysis."