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

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.

Study Overview

• Status: Completed
• Conditions: Food Insecurity; Overweight and Obesity; Weight Change, Body; Produce Prescription
• Intervention / Treatment: Behavioral: Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Grove City, Ohio, United States, 43123
      • Mid-Ohio Food Collective

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mid-Ohio Food Collective
• Collaborators: Weight Watchers International

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight; Body Weight Changes
• Other Study ID Numbers: 20222251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No