Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW
Primary Purpose
Food Insecurity, Overweight and Obesity, Produce Prescription
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)
Sponsored by
About this trial
This is an interventional other trial for Food Insecurity
Eligibility Criteria
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
Sites / Locations
- Mid-Ohio Food Collective
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)
Arm Description
Outcomes
Primary Outcome Measures
Total number of patients excluded (Feasibility and Acceptability)
Total number of patients excluded from participation in the intervention
Adherence to study activities (Feasibility and Acceptability)
Percent of study activities completed by each patient
Attrition rate (Feasibility and Acceptability)
Attrition rate (rate at which patients withdraw from the intervention)
Participant Satisfaction with the program (Feasibility and Acceptability)
Participant satisfaction with the intervention (Participant satisfaction questionnaires and semi-structured focus groups)
Food pantry visits (Feasibility and Acceptability)
Total number of food pantry visits prior to and following enrollment in the intervention
Secondary Outcome Measures
Change in body weight (Clinical Outcomes)
Change in body weight (lbs) from the beginning to the end of the intervention
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.
Change in blood pressure (Clinical Outcomes)
Change in blood pressure (mmHg) from the beginning to the end of the intervention.
Change in physical activity (Clinical Outcomes)
Change in physical activity (hours/minutes of activity) from the beginning to the end of the intervention.
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.
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)
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
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
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.
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.
Full Information
NCT ID
NCT05536518
First Posted
August 19, 2022
Last Updated
October 17, 2023
Sponsor
Mid-Ohio Food Collective
Collaborators
Weight Watchers International
1. Study Identification
Unique Protocol Identification Number
NCT05536518
Brief Title
Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW
Official Title
Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mid-Ohio Food Collective
Collaborators
Weight Watchers International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Insecurity, Overweight and Obesity, Produce Prescription, Weight Change, Body
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total number of patients excluded (Feasibility and Acceptability)
Description
Total number of patients excluded from participation in the intervention
Time Frame
Up to 8 months
Title
Adherence to study activities (Feasibility and Acceptability)
Description
Percent of study activities completed by each patient
Time Frame
Up to 8 months
Title
Attrition rate (Feasibility and Acceptability)
Description
Attrition rate (rate at which patients withdraw from the intervention)
Time Frame
Up to 8 months
Title
Participant Satisfaction with the program (Feasibility and Acceptability)
Description
Participant satisfaction with the intervention (Participant satisfaction questionnaires and semi-structured focus groups)
Time Frame
Up to 8 months
Title
Food pantry visits (Feasibility and Acceptability)
Description
Total number of food pantry visits prior to and following enrollment in the intervention
Time Frame
Up to 8 months
Secondary Outcome Measure Information:
Title
Change in body weight (Clinical Outcomes)
Description
Change in body weight (lbs) from the beginning to the end of the intervention
Time Frame
Up to 8 months
Title
Change in body mass index (BMI) (Clinical Outcomes)
Description
Change in BMI (weight (lb) / [height (in)]2 x 703) from the beginning to the end of the intervention.
Time Frame
Up to 8 months
Title
Change in blood pressure (Clinical Outcomes)
Description
Change in blood pressure (mmHg) from the beginning to the end of the intervention.
Time Frame
Up to 8 months
Title
Change in physical activity (Clinical Outcomes)
Description
Change in physical activity (hours/minutes of activity) from the beginning to the end of the intervention.
Time Frame
Up to 8 months
Title
Change in dietary intake (Clinical Outcomes)
Description
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.
Time Frame
Up to 8 months
Title
Change in food security status (SDOH Outcomes)
Description
Change in food security status from the beginning to the end of the intervention (food secure vs. food insecure)
Time Frame
Up to 8 months
Title
Change in economic trade-offs (SDOH Outcomes)
Description
Change in economic trade-offs (choices made between purchasing food and other necessities) from the beginning to the end of the intervention
Time Frame
Up to 8 months
Title
Change in health related quality of life (SDOH Outcomes)
Description
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
Time Frame
Up to 8 months
Title
Change in well-being (SDOH Outcomes)
Description
Change in well-being using the World Health Organisation-5 Well Being Index (WHO-5) from the beginning to the end of the intervention.
Time Frame
Up to 8 months
Title
Change in depression (SDOH Outcomes)
Description
Change in depression using the Patient Health Questionnaire-2 (PHQ-2) from the beginning to the end of the intervention.
Time Frame
Up to 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mid-Ohio Food Collective
City
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW
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