Clinical trial NCT05536518: 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
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Overweight and Obesity
Produce Prescription
Weight Change, Body
Lead sponsor: Mid-Ohio Food Collective
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2022-09-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Total number of patients excluded (Feasibility and Acceptability)
timeFrame: Up to 8 months
measure: Adherence to study activities (Feasibility and Acceptability)
timeFrame: Up to 8 months
measure: Attrition rate (Feasibility and Acceptability)
timeFrame: Up to 8 months
measure: Participant Satisfaction with the program (Feasibility and Acceptability)
timeFrame: Up to 8 months
measure: Food pantry visits (Feasibility and Acceptability)
timeFrame: Up to 8 months
Secondary outcomes:
measure: Change in body weight (Clinical Outcomes)
timeFrame: Up to 8 months
measure: Change in body mass index (BMI) (Clinical Outcomes)
timeFrame: Up to 8 months
measure: Change in blood pressure (Clinical Outcomes)
timeFrame: Up to 8 months
measure: Change in physical activity (Clinical Outcomes)
timeFrame: Up to 8 months
measure: Change in dietary intake (Clinical Outcomes)
timeFrame: Up to 8 months
measure: Change in food security status (SDOH Outcomes)
timeFrame: Up to 8 months
measure: Change in economic trade-offs (SDOH Outcomes)
timeFrame: Up to 8 months
measure: Change in health related quality of life (SDOH Outcomes)
timeFrame: Up to 8 months
measure: Change in well-being (SDOH Outcomes)
timeFrame: Up to 8 months
measure: Change in depression (SDOH Outcomes)
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Grove City
country: United States
facility: Mid-Ohio Food Collective
state: Ohio
Study officials:
References: