Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Medical University of South Carolina
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- body weight change (kg)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
To examine weight loss and acceptability of a modified WW program. This study is designed to detect differences in weight loss at the end of 24 weeks of intervention.
Detailed Description
This trial is an examination of a modified WW food program. The intention is to document the acceptability and efficacy of the dietary plan over 24 weeks. Subjects will participate in a program similar to WW Freestyle and have access to study-specific weekly workshops and a suite of study-specific digital tools for tracking eating, activity, and weight. Within a WW program, participants are provided instructions on calculating points for the foods and beverages they eat and drink. This study will examine the impact of the modified WW food program on weight and fitness levels of adults with overweight and obesity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ages 18-75 years
- •Body Mass Index (BMI) of 25 to 43
- •Self-reported desire 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)
- •Use of a personal iPhone on a daily basis
- •Basic app skills
- •Reliable home Wi-Fi access
- •Ability to commit to attending up to 27 study visits in approximately 26 weeks
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
body weight change (kg)
Time Frame: baseline to six months
average body weight change (kg) from baseline to six months
Secondary Outcomes
- flexibility(baseline, 3-months and 6-months)
- aerobic stamina(baseline, 3-months and 6-months)
- happiness(baseline, 3-months and 6-months)
- 3-month change in weight (kg)(baseline to 3-months)
- 6-month changes in body weight as a percentage of start weight(baseline to 6-months)
- changes in Body Mass Index (BMI)(baseline, 3-months and 6-months)
- 3-month change in weight, as a percentage of start weight(baseline to 3-months)
- waist circumference(baseline, 3-months and 6-months)
- food cravings(baseline, 3-months and 6-months)
- health related quality of life: SF-36(baseline, 3-months and 6-months)
- weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)(baseline, 3-months and 6-months)
- personal food assessment(baseline and 6-months)
- blood pressure(baseline, 3-months and 6-months)
- subjective sensations of hunger(baseline, 3-months and 6-months)
- program satisfaction: WW generated satisfaction questionnaire(3-months and 6-months)
- sleep quality and duration: Pittsburgh Sleep Quality Index(baseline, 3-months and 6-months)