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| Name | Class |
|---|---|
| WW International Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified WW Food program | Experimental | Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified WW Food program | Behavioral | Participants will receive a structured, holistic, behavioral weight management program that encourages development of healthy habits to help individuals eat healthier, move more, and shift to a more helpful mindset. |
| Measure | Description | Time Frame |
|---|---|---|
| body weight change (kg) | average body weight change (kg) from baseline to six months | baseline to six months |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month change in weight (kg) | average 3-month change in weight (kg) | baseline to 3-months |
| 3-month change in weight, as a percentage of start weight | 3-month change in weight, as a percentage of start weight |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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This single-armed trial will have one condition: the modified WW Food program.
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| baseline to 3-months |
| 6-month changes in body weight as a percentage of start weight | 6-month changes in body weight as a percentage of start weight | baseline to 6-months |
| changes in Body Mass Index (BMI) | changes in Body Mass Index (BMI) | baseline, 3-months and 6-months |
| waist circumference | change in waist circumference as measured at natural waist with a non-stretch tape measure. | baseline, 3-months and 6-months |
| flexibility | change in flexibility as measured via standard sit-and-reach protocol | baseline, 3-months and 6-months |
| aerobic stamina | change in aerobic stamina as measured with the 6-minute walk test | baseline, 3-months and 6-months |
| blood pressure | change in blood pressure as measured by a blood pressure monitor | baseline, 3-months and 6-months |
| food cravings | change in reported food cravings as measured by the FCI-II | baseline, 3-months and 6-months |
| happiness | change in reported happiness as measured using the Oxford Happiness Questionnaire | baseline, 3-months and 6-months |
| sleep quality and duration: Pittsburgh Sleep Quality Index | change in sleep quality and duration as measured by the Pittsburgh Sleep Quality Index | baseline, 3-months and 6-months |
| weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite) | change in reported weight related quality of life as measured by the Impact of Weight Related Quality of Life- Lite (IWQOL-Lite) | baseline, 3-months and 6-months |
| subjective sensations of hunger | change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale | baseline, 3-months and 6-months |
| personal food assessment | changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire | baseline and 6-months |
| program satisfaction: WW generated satisfaction questionnaire | program satisfaction as measured by the WW generated satisfaction questionnaire | 3-months and 6-months |
| health related quality of life: SF-36 | changes in reported health related quality of life as measured through the SF-36 | baseline, 3-months and 6-months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |