Evaluation of a Commercial Program on Weight Loss and Health Outcomes

Completed · Not applicable

Conditions studied: Weight Loss

In brief

While some evidence on weight change elicited from commercially available weight loss programs, such as Weight Watchers, is available, there is little evidence evaluating any health-related outcomes that result from losing weight through these programs. In addition, little data exists on the adherence and satisfaction of these types of programs. The purpose of this study is to evaluate body weight and health-related outcomes that are achieved from participating in a Weight Watchers program, along with program adherence and satisfaction. Men and women (N=150) that are participating in Weight Watchers weight loss program will undergo assessments at the University of Pittsburgh to evaluate outcomes related to the Weight Watchers 6 month intervention. Assessment visits, separate from the intervention, will take place at baseline (0 months), 3 months and 6 months for approximately 90 minutes at the Physical Activity and Weight Management Research Center. Participants will be asked to undergo assessments of body weight, height, aerobic stamina, functional fitness, flexibility, and complete a series of questionnaires related to demographics, program satisfaction, sleep quality, happiness, and food cravings. Adherence to the program will be measured by the number of group sessions attended.

Key facts

Study ID

NCT02585193

Run by

University of Pittsburgh

People needed

150

Starts

2015-08-01

Expected to finish

2016-03-01

Last updated by the study team

2017-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female over age 18. Set "soft quotas" on the number of male and female participants - The desire is to have a 90% female / 10% male split.
• With or without previous Weight Watchers experience. Set quota on the number of participants with previous Weight Watchers experience at 65%.
• Self reported height/weight resulting in a Body Mass Index (BMI) of 27 to 43 kg/m2 (will re-screen at facility).
• Self report that he/she feels the need to lose weight.
• Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement.
• Willing to follow recommendations required by study protocol.
• Willing to include demographic information (e.g., ethnicity, income and education).
• Willing to participate in consumer surveys and focus groups as a part of the intervention.
• Use of a personal smartphone on a daily basis. For Android devices, must be version 4.4 (code: KitKat) or 5.0 (codename: Lollipop). For iPhones, must be iOS6 and above. Cannot accommodate Blackberry devices.
• The willingness and ability to navigate and use applications on their smartphone on a daily basis (minimum training will be provided).
• Reliable home WiFi access
• Ability to commit to attending up to 27 study visits in approximately 26 weeks:
• Ability to commit (to best of their ability) to attending weekly meetings, 30-60 minutes in duration, at the same day and time each week for 24 consecutive weeks (daytime and evening options will be available).
• Ability to commit to up to 3 additional study visits at Weeks 0, 12, and 24, each approximately 90 minutes in duration, to complete assessments (height, weight, questionnaires, physical measures).

You may not qualify if…

• Participants that are currently following a commercial weight-loss program.
• Participants that have been involved in a related market research program within the last 6 months.
• Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
• Recent weight loss of ≥ 5 kg in the previous 3 months.
• History of clinically diagnosed eating disorder.
• Orthopedic limitations preventing participation in regular physical activity.
• Untreated thyroid disease or > 1 change in dose or type of thyroid medication over previous 6 months.
• Taking any prescription medication with known effects on appetite or weight.
• With the exception of subjects on a stable dose of SSRIs (Selective Serotonin Re-uptake Inhibitors) for 6 months.
• Taking oral steroids.
• Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome acceptable).
• Previous surgical procedure for weight loss.
• Major surgery within the previous 3 months.
• History of heart problems (e.g., angina, bypass surgery, MI, etc) within previous 3 months.
• Presence of implanted cardiac defibrillator or pacemaker.
• Uncontrolled hypertension self-reported BP > 160/100mmHg)
• Diuretic use for hypertension over 1.5mg per day
• Diagnosis of type 1 or type 2 diabetes
• History of presence of cancer (completely respected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
• Consuming more than 14 alcoholic drinks per week or not more than 3 drinks per day.
• Planning to relocate in the next 9 months
• Any orthopedic limitation preventing participation in regular physical activity.

Where it is running

• Physical Activity and Weight Management Research Center / University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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