The Effects of a Commercially Available Weight Loss Program on Body Weight in Overweight Men and Women

NCT03070015 | Completed

• 1 other identifier: NUTR001-2015
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study (Part A) is to assess changes in body weight and body circumference parameters that are achievable after 4 weeks on the Nutrisystem program compared to a self-directed diet (i.e. Dietary Approaches to Stop Hypertension or DASH). In Part B, subjects on the Nutrisystem program will be given the option to continue the program for another 8 weeks.

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, and 4 for Parts A \& B; plus week 8, 12 for Part B)

  up to 4 weeks (Part A); up to 12 weeks (Part B)

Secondary Outcomes (6)

• Waist Circumference

  up to 4 weeks (Part A); up to 12 weeks (Part B)

• Hip Circumference

  up to 4 weeks (Part A); up to 12 weeks (Part B)

• Chest Circumference

  up to 4 weeks (Part A); up to 12 weeks (Part B)

• Arm Circumference

  up to 4 weeks (Part A); up to 12 weeks (Part B)

• Thigh Circumference

  up to 4 weeks (Part A); up to 12 weeks (Part B)

Study Arms (2)

Nutrisystem

EXPERIMENTAL

All subjects received Nutrisystem pre-packaged, portion-controlled foods and followed the Nutrisystem program for a total of 12 weeks (4 weeks for Part A, and an additional 8 weeks for Part B)

Behavioral: Nutrisystem

Self-Directed DASH

ACTIVE COMPARATOR

All subjects provided publically available information on the DASH diet and a sample meal plan. Subjects were instructed to follow a reduced calorie DASH diet meal plan on their own for 4 weeks (Part A only).

Behavioral: Self-Directed DASH

Interventions

Nutrisystem BEHAVIORAL

The Nutrisystem Diet was 1000 kcal/day for week 1,and 1200 calories/day for women and 1500 calories/day for men after week 1.Subjects with BMI \> 40 added 200 extra calories/day through grocery food add-ins.Subjects received 7 breakfast,7 lunches,7 dinners, and 14 shakes for week 1.Subjects added in vegetables \& no-calorie beverages in week 1.After week 1,Nutrisystem provided 7 breakfasts,6 lunches,6 dinners, and 7 (women) or 14 (men) snacks/week.Subjects prepared 1 lunch \& 1 dinner on their own weekly. Guidelines were given to allow subjects to select foods that fit within plan guidelines (\~50% kcal from carbohydrate,\~25% from protein,\~25% from fat). Nutrisystem foods were about 60% of kcal target; grocery additions made the balance.Subjects received guidance as typical on Nutrisystem throughout the study period.Subjects were encouraged to call Nutrisystem counselors. Subjects randomized to this participated in Part A (4 weeks) and Part B (additional 8 weeks) of the study.

Nutrisystem

Self-Directed DASH BEHAVIORAL

The self-directed Dietary Approaches to Stop Hypertension group received instruction/education with handouts \& sample meal plans, which met guidelines for DASH. All subjects followed a 1000 kcal/day DASH diet for week 1. After week 1, women ate 1200 kcal/day \& men ate 1500 kcal/day. Subjects with BMI \>40 added an extra 200 kcal/day. Subjects randomized to this group received one additional educational session beyond the Randomization visit on how to follow their prescribed meal plan. Subjects in this group only participated in Part A (4-weeks) of the study.

Self-Directed DASH

Eligibility Criteria

• Age: 19 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, 19-70 years of age, inclusive.
• Subject has a BMI of 25.00 to 44.99 kg/m2 at the Screening visit.
• Subject is a non-smoker.
• Female study participants ages 19-49 must be on a steady dose of oral contraceptives (OCA) \[to reduce weight variability secondary to changes that occur with the luteal phase of menses\]. Stable dose was defined as same dose for at least past 90 days. Female study participants that are 50 or over who are not currently on birth control but are weight stable for at least the prior three months were enrolled.
• 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.
• Subject agrees to follow the instructions and meal plans per the randomization into Nutrisystem or Self-Directed.
• 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:

• Females with prior diagnosis of premenstrual syndrome or Premenstrual dysphoric disorder (PMDD).
• Subject has an abnormal laboratory test result of clinical significance at the Screening visit that upon re-testing has not normalized (per physician discretion).
• Subject has had a weight loss or gain ≥10 lb (4.5 kg) in the three (3) months prior to Visit 1 (Week -1).
• Subject has used weight loss medications within the past three months of Screening visit.
• Subject has dietary tendencies that may be representative of disordered eating (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 previously been diagnosed diabetes mellitus (type 1 or type 2) or fasting glucose ≥126 mg/dL at the screening visit.
• Subject is on thyroid medication at a dose that is not considered stable. Stable is same dose consistently for at least 90 days.
• Subject has used any prescription weight loss medications within three months prior to Screening Visit, and any dietary supplements or programs intended to alter body weight within the last four weeks.
• Subject has used any prescription Corticosteroids (oral or systemic) within past three months.
• Subjects using medications and dietary supplements likely to markedly affect appetite or metabolic rate (e.g., beta-blockers) may be excluded, based on the judgment of the Investigator (with washout prior to study randomization).
• 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 sign/symptoms of an infection. The randomization visit 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 that is known to affect nutrient absorption or body weight.

Sponsors & Collaborators

• Nutrisystem, Inc.: lead
• The Center for Applied Health Sciences: collaborator
• Omega Statistics: collaborator

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

• Tim N Ziegenfuss, Ph.D., FISSN, CSCS

  The Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share