Study to Evaluate Effects of a Weight Loss Program in Different Formats on Healthy Adults
Condition: Overweight and Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The objective of this study was to determine changes in body weight and related outcomes
      achievable over a 16-week period in response to three different commercially available weight
      loss programs (Nutrisystem) providing pre-packed, portion controlled foods and beverages,
      each compared to a self-directed diet, in apparently healthy overweight and obese men and
      women.
    

Detailed description: 
      A randomized, controlled, four-arm parallel study design included two screening/baseline
      visits (visits 1 and 2; weeks -1 and 0) and six clinic visits (visits 3, 4, 5, 6, 7, 8, and
      9; weeks 1, 2, 3, 4, 8, 12, and 16). One hundred and eighty healthy overweight and obese men
      and women (18-70 years of age; Body Mass Index 25.00 to 44.99 kg/m2) were randomly assigned
      (stratified randomization by two BMI and three age categories) to one of four treatment arms:
      a self-directed diet, or one of three different Nutrisystem programs: 1) My Way; 2) Turbo 10;
      or 3) a program modeled after the Dietary Approaches to Stopping Hypertension (DASH) diet.
      Daily energy intake targets for each 16-week intervention were 1500 kcal/day (men) or 1200
      kcal/day (women), except for the first week of the Turbo 10 intervention, which included a
      more aggressive 1000 kcal/day diet to start. Body weight, body circumference (chest, waist,
      hip, upper arm, thigh and sum of the 5), and blood pressure measurements were obtained at
      baseline (week 0) and at weeks 1, 2, 3, 4, 8, 12, and 16 in the morning following an
      overnight fast (9 to 14 hours). Total and regional fat mass and fat-free mass (lean soft
      tissue and bone) were quantified by dual energy x-ray absorptiometry at baseline (week 0) and
      at weeks 4, 8, and 16. Analyses of serum lipoprotein lipids were obtained at baseline (week
      0), week 8, and week 16. Lipoprotein lipid assessments included Total Cholesterol (TC),
      LDL-Cholesterol, HDL-Cholesterol, non-HDL-Cholesterol (calculated as TC minus HDL-C),
      Triglycerides, and the Total Cholesterol/HDL-Cholesterol ratio. Plasma chemistry and
      whole-blood hematology analyses were conducted at screening (week -1). Questionnaires
      designed to assess aspects of quality of life and sleep quality were administered at baseline
      (week 0) and weeks 4, 8, and 16. Quality of Life assessments included the Impact of Weight on
      Quality of Life-Lite (IQWOL-Lite), 36-Item Short Form Health Survey (SF-36), and Leeds Sleep
      Evaluation Questionnaire (LSEQ).
    

Intervention name(s): Nutrisystem Turbo 10; Nutrisystem My Way; Nutrisystem DASH; Dieting on Your Own (DIY) - DASH
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Turbo10 plan provided approx. 1000 kcal/d for all subjects and included portion controlled foods/shakes for the first week (week 0). All food, except non-starchy vegetables and no-calorie beverages, was provided for the first week (week 0). Starting week 1, subjects followed the My Way plan intervention through week 16.; The Nutrisystem My Way plan provided 7 breakfasts, 6 lunches, 6 dinners, and 7 (women) or 14 (men) snacks/desserts as pre-packaged portion controlled foods every week. Subjects were instructed to prepare one lunch and one dinner on their own each week. General guidelines and recommendations were provided by Nutrisystem in order to allow subjects to self-select appropriate foods for these eating occasions that fit within the My Way plan guidelines (~50% kcal from carbohydrate, ~25% from protein, ~25% from fat). Women were assigned to 1200 calories per day and men were assigned to 1500 calories per day. Nutrisystem packaged foods accounted for approximately 60% of daily calorie target; recommended grocery food additions (which subjects purchased on their own) accounted for the balance.; The Nutrisystem DASH plan was a modification of the My Way plan designed to meet the nutrition profile of the DASH Diet, as described in NIH materials. Key nutritional targets included < 30% fat (< 7% saturated fat), < 150 mg/d of cholesterol, and < 2300 mg/d of sodium. Key dietary targets were consumption of 7-10 servings of fruit/vegetables/day, 2-3 servings of low-fat dairy/day, and 3 servings nuts/seeds/week. The Nutrisystem DASH plan included a subset of the Nutrisystem menu [7 breakfasts, 6 lunches, 6 dinners, plus snacks as portion-controlled foods every week], as well as modified guidelines for grocery additions, to achieve the nutrition targets of the DASH diet. Women consumed 1200 kcal/day and men consumed 1500 kcal/day.; The self-directed diet included publicly available information consistent with the Dietary Approaches to Stop Hypertension (DASH) diet instructing individuals to consume a reduced calorie diet to support self-directed weight loss efforts. Women were assigned to a 1200 calorie diet and men were assigned to a 1500 calorie diet. Information on the self-directed diet was provided at the beginning of the intervention (visit 2, week 0). Subjects randomized to this group did not receive additional dietary counseling throughout the study period.
Other intervention name(s): Self-directed Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; Obesity; Overweight