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

NCT03017443 | Completed

• 1 other identifier: BIO-1507
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Weight Loss; Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Change in body weight from baseline (week 0) to each post-randomization visit (week 1, 2, 3, 4, 8, 12, and 16).

  Up to 16 weeks

Secondary Outcomes (17)

• Waist Circumference

  Up to 16 weeks

• Hip Circumference

  Up to 16 weeks

• Chest circumference

  Up to 16 weeks

• Upper arm circumference

  Up to 16 weeks

• Thigh circumference

  Up to 16 weeks

Study Arms (4)

Nutrisystem My Way

EXPERIMENTAL

All subjects received Nutrisystem pre-packaged, portion-controlled foods and followed the Nutrisystem My Way plan.

Behavioral: Nutrisystem My Way

Nutrisystem Turbo 10

EXPERIMENTAL

All subjects received Nutrisystem pre-packaged, portion-controlled foods and followed the Nutrisystem Turbo 10 plan.

Behavioral: Nutrisystem Turbo 10

Nutrisystem DASH

EXPERIMENTAL

All subjects received Nutrisystem pre-packaged, portion-controlled foods and followed the Nutrisystem DASH plan.

Behavioral: Nutrisystem DASH

Dieting on Your Own (DIY) - DASH

ACTIVE COMPARATOR

All subjects provided publically available information on the DASH diet and instructed to follow a reduced calorie DASH diet meal plan on their own.

Behavioral: Dieting on Your Own (DIY) - DASH

Interventions

Nutrisystem Turbo 10 BEHAVIORAL

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.

Nutrisystem Turbo 10

Nutrisystem My Way BEHAVIORAL

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.

Nutrisystem My Way

Nutrisystem DASH BEHAVIORAL

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.

Nutrisystem DASH

Dieting on Your Own (DIY) - DASH BEHAVIORAL

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.

Also known as: Self-directed Diet

Dieting on Your Own (DIY) - DASH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female, 18-70 years of age, inclusive.
• Subject has a body mass index (BMI) of 25.00 to 44.99 kg/m2, inclusive, at visits 1 and 2 (weeks -1 and 0).
• Subject has no plans to change smoking habits during the study period.
• Subject is willing to follow study program instructions, including avoidance of all non-study-related food and beverages.
• Subject is willing and able to comply with the visit schedule \[i.e., no visit window will be allowed between visits 2 and 3 (week 0 and 1) and visits 3 and 4 (weeks 1 and 2)\].
• Subject agrees to follow the physical activity recommendations as outlined in each plan.
• If a premenopausal female, subject has a history of regular menstrual cycles that range in length from 21 to 35 d, where applicable.
• Judged to be in good health on the basis of medical history and screening laboratory assessments.
• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.

You may not qualify if:

• Subject has an abnormal laboratory test result of clinical significance at visit 1 (week -1), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to visit 2 (week 0) for subjects with abnormal laboratory test results.
• Subject has had a weight loss or gain ≥10 lb (4.5 kg) in the 6 months prior to visit 1 (week -1).
• Subject has used weight loss medications within 6 months of visit 1 (week -1) or weight loss supplements or programs, other than those provided, intended to alter body weight within 4 weeks of visit 1 (week -1) or during the course of the study (Appendix 1).
• Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.
• Subject has a known allergy, sensitivity, or intolerance to the study foods or any ingredients of the study menu provided.
• Subject has diagnosed diabetes mellitus (type 1 or type 2) or fasting glucose ≥126 mg/dL at the screening visit (visit 1, week -1).
• Subject has used thyroid hormones, except stable-dose replacement therapy for ≥2 months prior to visit 1 (week -1; Appendix 1).
• Subject has used dietary supplements that, in the judgment of the Investigator, are likely to markedly affect appetite. The washout period will be 2 weeks prior to visit 1 (week -1; Appendix 1).
• Subject has used medications or supplements that may influence carbohydrate metabolism, including but not limited to hypoglycemic medications and systemic (intravenous, intramuscular, or oral) or ≥1500 µg/d topical (inhaled, intranasal, or dermal) corticosteroids within 4 weeks of visit 1 (week -1) and throughout the study (Appendix 1).
• Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurologic disorders.
• Subject has an active gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
• Subject has an active infection or signs/symptoms of an infection. The baseline visit (visit 2, week 0) will be re-scheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days.
• Subject has a history of gastrointestinal surgery for weight reducing purposes.
• Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the blood pressure measured at visit 1 (week -1). One re-test will be allowed on a separate day prior to visit 2 (week 0) for subjects whose blood pressure exceeds either of these cut points at visit 1.
• Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.

Sponsors & Collaborators

• Nutrisystem, Inc.: lead
• Biofortis Clinical Research, Inc.: collaborator

Related Publications (1)

• Cook CM, McCormick CN, Knowles M, Kaden VN. A Commercially Available Portion-Controlled Diet Program Is More Effective for Weight Loss than a Self-Directed Diet: Results from a Randomized Clinical Trial. Front Nutr. 2017 Nov 7;4:55. doi: 10.3389/fnut.2017.00055. eCollection 2017.

  PMID: 29164129 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Kathleen M Kelley, MD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

• Chad M Cook, PhD

  Biofortis Innovation Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 11, 2017
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share