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

NCT05536518 | Completed

• 1 other identifier: 20222251
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Change in body weight (Clinical Outcomes)

  Up to 8 months

• Change in body mass index (BMI) (Clinical Outcomes)

  Up to 8 months

• Change in blood pressure (Clinical Outcomes)

  Up to 8 months

• Change in physical activity (Clinical Outcomes)

  Up to 8 months

• Change in dietary intake (Clinical Outcomes)

  Up to 8 months

Study Arms (1)

Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)

OTHER

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

Interventions

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.

Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid-Ohio Food Collective: lead
• WW International Inc: collaborator

Study Sites (1)

Mid-Ohio Food Collective

Grove City, Ohio, 43123, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Body Weight Changes

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 13, 2022
• Study Start: July 21, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)