Evaluation of a Commercial Program on Weight Loss and Health Outcomes

NCT02585193 | Completed

• 1 other identifier: PRO15040047
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Body Weight Change

  To examine the effect of a 24-week commercially available weight loss program on weight change.

  6 months

Secondary Outcomes (6)

• Change in Sleep Quality and Duration

  6 months

• Change in Happiness

  6 months

• Change in Food Cravings

  6 months

• Program Satisfaction

  6 months

• Program Adherence

  6 months

Study Arms (1)

Weight Watchers Intervention

OTHER

All participants are enrolled in this single arm of the study. All participants receive the Weight Watchers intervention which consists of weekly group intervention/support meetings in which weight loss behaviors (diet, physical activity) are discussed.

Behavioral: Weight Watchers Intervention

Interventions

Weight Watchers Intervention BEHAVIORAL

All participants are enrolled in this single arm of the study. All participants receive the Weight Watchers intervention which consists of weekly group intervention/support meetings in which weight loss behaviors (diet, physical activity) are discussed.

Weight Watchers Intervention

Eligibility Criteria

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

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Physical Activity and Weight Management Research Center / University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Renee J Rogers, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 23, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (1)