Study to Evaluate Effects of a Weight Loss Program in Different Formats on Healthy Adults

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.

Conditions

• Overweight and Obesity
• Weight Loss

Interventions

BEHAVIORAL

Nutrisystem Turbo 10

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.

BEHAVIORAL

Nutrisystem My Way

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.

BEHAVIORAL

Nutrisystem DASH

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.

BEHAVIORAL

Dieting on Your Own (DIY) - DASH

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.

Sponsors & Collaborators

• Biofortis Clinical Research, Inc.

  collaborator INDUSTRY

• Nutrisystem, Inc.

  lead INDUSTRY

Principal Investigators

• Kathleen M Kelley, MD · Biofortis Innovation Services

• Chad M Cook, PhD · Biofortis Innovation Services

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2015-10-31

Completion

2015-10-31