Food InsecurityNCT05536518
Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW
A study testing Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual) in people with Food Insecurity and Overweight and Obesity, run by Mid-Ohio Food Collective at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Insecurity, Overweight and Obesity, Produce Prescription
- What is being tested?
- Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)
- Medical subject headings
- Overweight, Obesity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual) | Other | Not described Receives: Behavioral: Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of patients excluded (Feasibility and Acceptability)
Total number of patients excluded from participation in the intervention
Measured: Up to 8 months
Adherence to study activities (Feasibility and Acceptability)
Percent of study activities completed by each patient
Measured: Up to 8 months
Attrition rate (Feasibility and Acceptability)
Attrition rate (rate at which patients withdraw from the intervention)
Measured: 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)
Measured: Up to 8 months
Food pantry visits (Feasibility and Acceptability)
Total number of food pantry visits prior to and following enrollment in the intervention
Measured: Up to 8 months
Secondary outcomes (10)
Change in body weight (Clinical Outcomes)
Change in body weight (lbs) from the beginning to the end of the intervention
Measured: 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.
Measured: Up to 8 months
Change in blood pressure (Clinical Outcomes)
Change in blood pressure (mmHg) from the beginning to the end of the intervention.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start21 Jul 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid-Ohio Food Collective
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536518
- Sponsor's protocol ID
- 20222251
- Status last verified
- Oct 2023
- First submitted
- 19 Aug 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW
- ClinicalTrials.gov ID
- NCT05536518
- Acronym / sponsor ID
- 20222251
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mid-Ohio Food CollectiveUniversity, hospital or other
- Collaborators
- WW International Inc
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual) |
Primary outcome
Total number of patients excluded (Feasibility and Acceptability)
Time frame: Up to 8 months
Total number of patients excluded from participation in the intervention
Adherence to study activities (Feasibility and Acceptability)
Time frame: Up to 8 months
Percent of study activities completed by each patient
Attrition rate (Feasibility and Acceptability)
Time frame: Up to 8 months
Attrition rate (rate at which patients withdraw from the intervention)
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)
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
10 secondary outcomes
Change in body weight (Clinical Outcomes)
Time frame: Up to 8 months
Change in body mass index (BMI) (Clinical Outcomes)
Time frame: Up to 8 months
Change in blood pressure (Clinical Outcomes)
Time frame: Up to 8 months
Change in physical activity (Clinical Outcomes)
Time frame: Up to 8 months
Change in dietary intake (Clinical Outcomes)
Time frame: Up to 8 months
Change in food security status (SDOH Outcomes)
Time frame: Up to 8 months
Change in economic trade-offs (SDOH Outcomes)
Time frame: Up to 8 months
Change in health related quality of life (SDOH Outcomes)
Time frame: Up to 8 months
Change in well-being (SDOH Outcomes)
Time frame: Up to 8 months
Change in depression (SDOH Outcomes)
Time frame: Up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mid-Ohio Farmacy (produce prescription) + WW International Coaching (In person and/or Virtual) in people with Food Insecurity and Overweight and Obesity, run by Mid-Ohio Food Collective at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of patients excluded (Feasibility and Acceptability) (time frame: Up to 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.