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| Name | Class |
|---|---|
| WW International Inc | INDUSTRY |
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The aim of this research is to undertake a feasibility study to assess uptake and impact of providing access to a widely available weight management and wellness program (WW; formerly known as Weight Watchers) among individuals experiencing food insecurity and overweight/obesity, who are eligible to receive weekly produce at the Mid-Ohio Food Collective (MOFC) through their pre-existing enrollment in the Mid-Ohio Farmacy program. Participants (n=90) adults over the age of 18 with a BMI between 27-50 kg/m2 will be recruited for a 6 month single-arm clinical trial, where participants will be provided with WW Unlimited Workshop + Digital. The primary objective is to test the feasibility and acceptability of a commercial weight loss and wellness program with an established produce prescription program among individuals experiencing food insecurity and overweight/obesity. Secondary outcomes will include assessments related to weight, height, blood pressure, dietary intake, physical activity, food access, depression, wellbeing and economic factors.
This feasibility study will help inform future interventions among this population. More specifically, this study will help answer questions about the feasibility and acceptability of such an intervention, adherence to the WW program as described to the participant, and the impact that access to a free weight management and wellness program can have on health-related outcomes among individuals experiencing food insecurity and overweight/obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual) | Behavioral | All study participants are members of the Mid-Ohio Farmacy produce prescription program. All participants are food insecure and will be enrolled and participate in WW coaching sessions for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of patients excluded (Feasibility and Acceptability) | Total number of patients excluded from participation in the intervention | Up to 8 months |
| Adherence to study activities (Feasibility and Acceptability) | Percent of study activities completed by each patient | Up to 8 months |
| Attrition rate (Feasibility and Acceptability) | Attrition rate (rate at which patients withdraw from the intervention) | Up to 8 months |
| Participant Satisfaction with the program (Feasibility and Acceptability) | Participant satisfaction with the intervention (Participant satisfaction questionnaires and semi-structured focus groups) | Up to 8 months |
| Food pantry visits (Feasibility and Acceptability) | Total number of food pantry visits prior to and following enrollment in the intervention | Up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (Clinical Outcomes) | Change in body weight (lbs) from the beginning to the end of the intervention | Up to 8 months |
| Change in body mass index (BMI) (Clinical Outcomes) | Change in BMI (weight (lb) / [height (in)]2 x 703) from the beginning to the end of the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid-Ohio Food Collective | Grove City | Ohio | 43123 | United States |
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| Up to 8 months |
| Change in blood pressure (Clinical Outcomes) | Change in blood pressure (mmHg) from the beginning to the end of the intervention. | Up to 8 months |
| Change in physical activity (Clinical Outcomes) | Change in physical activity (hours/minutes of activity) from the beginning to the end of the intervention. | Up to 8 months |
| Change in dietary intake (Clinical Outcomes) | Change in frequency of consumption of fruits/vegetables, whole grain foods and low fat dairy/dairy alternatives from the beginning to the end of the intervention. | Up to 8 months |
| Change in food security status (SDOH Outcomes) | Change in food security status from the beginning to the end of the intervention (food secure vs. food insecure) | Up to 8 months |
| Change in economic trade-offs (SDOH Outcomes) | Change in economic trade-offs (choices made between purchasing food and other necessities) from the beginning to the end of the intervention | Up to 8 months |
| Change in health related quality of life (SDOH Outcomes) | Change in health related quality of life using the CDC Health Related Quality of Life Healthy Days Core Module (HRQOL-4) from the beginning to the end of the intervention | Up to 8 months |
| Change in well-being (SDOH Outcomes) | Change in well-being using the World Health Organisation-5 Well Being Index (WHO-5) from the beginning to the end of the intervention. | Up to 8 months |
| Change in depression (SDOH Outcomes) | Change in depression using the Patient Health Questionnaire-2 (PHQ-2) from the beginning to the end of the intervention. | Up to 8 months |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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