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OpenTrials
Completed

NCT Number: NCT05536518

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.

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Key information

Conditions

Food Insecurity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Produce Prescription Signs and Symptoms Weight Change, Body

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid-Ohio Food Collective

Grove City, Ohio, 43123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Total number of patients excluded (Feasibility and Acceptability)

    Time frame: Up to 8 months

    Total number of patients excluded from participation in the intervention

  2. Adherence to study activities (Feasibility and Acceptability)

    Time frame: Up to 8 months

    Percent of study activities completed by each patient

  3. Attrition rate (Feasibility and Acceptability)

    Time frame: Up to 8 months

    Attrition rate (rate at which patients withdraw from the intervention)

  4. Participant Satisfaction with the program (Feasibility and Acceptability)

    Time frame: Up to 8 months

    Participant satisfaction with the intervention (Participant satisfaction questionnaires and semi-structured focus groups)

  5. Food pantry visits (Feasibility and Acceptability)

    Time frame: Up to 8 months

    Total number of food pantry visits prior to and following enrollment in the intervention

Secondary outcomes

  1. Change in body weight (Clinical Outcomes)

    Time frame: Up to 8 months

    Change in body weight (lbs) from the beginning to the end of the intervention

  2. Change in body mass index (BMI) (Clinical Outcomes)

    Time frame: Up to 8 months

    Change in BMI (weight (lb) / [height (in)]2 x 703) from the beginning to the end of the intervention.

  3. Change in blood pressure (Clinical Outcomes)

    Time frame: Up to 8 months

    Change in blood pressure (mmHg) from the beginning to the end of the intervention.

  4. Change in physical activity (Clinical Outcomes)

    Time frame: Up to 8 months

    Change in physical activity (hours/minutes of activity) from the beginning to the end of the intervention.

  5. Change in dietary intake (Clinical Outcomes)

    Time frame: Up to 8 months

    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.

  6. Change in food security status (SDOH Outcomes)

    Time frame: Up to 8 months

    Change in food security status from the beginning to the end of the intervention (food secure vs. food insecure)

  7. Change in economic trade-offs (SDOH Outcomes)

    Time frame: Up to 8 months

    Change in economic trade-offs (choices made between purchasing food and other necessities) from the beginning to the end of the intervention

  8. Change in health related quality of life (SDOH Outcomes)

    Time frame: Up to 8 months

    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

  9. Change in well-being (SDOH Outcomes)

    Time frame: Up to 8 months

    Change in well-being using the World Health Organisation-5 Well Being Index (WHO-5) from the beginning to the end of the intervention.

  10. Change in depression (SDOH Outcomes)

    Time frame: Up to 8 months

    Change in depression using the Patient Health Questionnaire-2 (PHQ-2) from the beginning to the end of the intervention.

Sponsors and collaborators

Lead sponsor

Mid-Ohio Food Collective

Other

Collaborators

  • WW International Inc

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2022
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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