Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW

Conditions
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Food Insecurity, Overweight and Obesity, Produce Prescription, Weight Change, Body

Intervention / Treatment
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* Behavioral: Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 year or older BMI 27-50 kg/m2 Positive screen for food insecurity at healthcare provider Enrolled in Mid-Ohio Farmacy (produce prescription program) Speak English Live in greater Columbus,Ohio area for duration of study Reliable internet access Ability to download and install WW app on phone Exclusion Criteria: Participation in a structured weight loss program in the last 12 months WW membership in the last 12 months Pregnant, nursing or planning to become pregnant Weight loss of 5kg or more in the past 6 months Taking prescription medications for weight loss

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)<br> | Behavioral: Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |