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

NCT ID: NCT03017443

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-10-31

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.

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).

Conditions

Overweight and Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutrisystem My Way

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

Group Type: EXPERIMENTAL

Nutrisystem My Way

Intervention Type: 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 Turbo 10

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

Group Type: EXPERIMENTAL

Nutrisystem Turbo 10

Intervention Type: 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 DASH

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

Group Type: EXPERIMENTAL

Nutrisystem DASH

Intervention Type: 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.

Dieting on Your Own (DIY) - DASH

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

Group Type: ACTIVE_COMPARATOR

Dieting on Your Own (DIY) - DASH

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Self-directed Diet

Eligibility Criteria

Inclusion Criteria

1. Subject is male or female, 18-70 years of age, inclusive.

2. 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).

3. Subject has no plans to change smoking habits during the study period.

4. Subject is willing to follow study program instructions, including avoidance of all non-study-related food and beverages.

5. 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)].

6. Subject agrees to follow the physical activity recommendations as outlined in each plan.

7. If a premenopausal female, subject has a history of regular menstrual cycles that range in length from 21 to 35 d, where applicable.

8. Judged to be in good health on the basis of medical history and screening laboratory assessments.

9. 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.

Exclusion Criteria

1. 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.

2. Subject has had a weight loss or gain ≥10 lb (4.5 kg) in the 6 months prior to visit 1 (week -1).

3. 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).

4. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.

5. Subject has a known allergy, sensitivity, or intolerance to the study foods or any ingredients of the study menu provided.

6. Subject has diagnosed diabetes mellitus (type 1 or type 2) or fasting glucose ≥126 mg/dL at the screening visit (visit 1, week -1).

7. Subject has used thyroid hormones, except stable-dose replacement therapy for ≥2 months prior to visit 1 (week -1; Appendix 1).

8. 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).

9. 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).

10. Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurologic disorders.

11. Subject has an active gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).

12. 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.

13. Subject has a history of gastrointestinal surgery for weight reducing purposes.

14. 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.

15. Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.

16. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.

17. Subject is a premenopausal female using a form of hormonal contraception that does not result in a normal menstrual cycle, including a regular menses period.

18. Subject has a recent history of (within 12 months of visit 1, week -1) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).

19. Exposure to any non-registered drug product within 30 d prior to the screening visit (visit 1).

20. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biofortis Clinical Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Nutrisystem, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen M Kelley, MD

Role: PRINCIPAL_INVESTIGATOR

Biofortis Innovation Services

Chad M Cook, PhD

Role: STUDY_DIRECTOR

Biofortis Innovation Services

References

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.

Reference Type: DERIVED

PMID: 29164129 (View on PubMed)

Other Identifiers

BIO-1507

Identifier Type: -

Identifier Source: org_study_id