ObesityNCT05174078
Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
A study testing Medically-tailored meals and Produce box and recipes in people with Obesity and Hypertension, run by Cleveland Clinic Akron General at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Hypertension, Pre-diabetes
- What is being tested?
- Medically-tailored meals and Produce box and recipes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 30 Dec 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
- Adults 18 years of age or older who are patients at Akron General Center for Family Medicine
- Have body mass index (BMI) equal to or greater that 30kg/m2 AND
- Have at least one of the following diagnoses determined based on patients' problem list in the electronic medical record (EMR) and the international classification of diseases, 10th revision (ICD-10) codes:
- Pre-type 2 diabetes mellitus
- Type 2 diabetes mellitus
- Hypertension
- Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months
Who cannot join
- Food allergies
- Pregnant
- No access to internet
- Need English language interpretation
- Currently participating in a structured weight loss program or using weight loss medications
- Any condition that, in the Investigator's judgement, interferes with the ability to adhere to study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level.
The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.
Read the detailed description
Participants will receive healthy food items for 15 weeks and nutrition counseling and education to support chronic disease management at no cost. The healthy food items will consist of either medically-tailored pre-prepared meals, or a weekly produce box with recipes depending on the study arm. Participants must complete a baseline study visit, one nutritional counseling session via phone, 2 to 4 nutrition education videos, and a 16-week post-intervention study visit.
- Conditions
- Obesity, Hypertension, Pre-diabetes, Type 2 Diabetes
- Being tested
- Medically-tailored meals, Produce box and recipes
- Medical subject headings
- Obesity, Hypertension, Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically-tailored mealsOther
Medically tailored meals delivered to patients' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.
Produce box and recipesOther
Weekly produce box and access to recipes via internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.
| Study group | Role | What they receive |
|---|---|---|
| Medically-Tailored Meals (MTM) | Experimental | Medically-tailored meals delivered to participants' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. Receives: Other: Medically-tailored meals |
| Produce Box and Recipes | Experimental | Weekly produce box delivered to participants' homes and access to recipes via the internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. Receives: Other: Produce box and recipes |
| Standard of Care | No intervention | Matched controls from the same base population as participants in the intervention arms. Controls will identified from the electronic medical record (EMR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participants' body weight
Percent weight loss
Measured: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Secondary outcomes (13)
Pre-type 2 diabetes mellitus: Change in number of medications
Absolute change in number of medications
Measured: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Pre-type 2 diabetes mellitus: Change in medication dosage
Percent change in medication dosage
Measured: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Pre-type 2 diabetes mellitus: Change in HbA1c
Absolute change in HbA1c
Measured: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in number of medications
Absolute change in number of medications
Measured: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in medication dosage
Percent change in medication dosage
Measured: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in HbA1c
Absolute change in HbA1c
Measured: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Hypertension: Change in number of medications
Absolute change in number of medications
Measured: Baseline visit (W1) to 16 week visit
Hypertension: Change in medication dosage
Percent change in medication dosage
Measured: Baseline visit (W1) to 16 week visit
Receipt of healthy food items: The Hunger Vital Sign scale
Values on the scale are: often true, sometimes true, and never true. A positive response to either or both of the first two values (often true, sometimes true) identifies households as being at risk for food insecurity
Measured: Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Eating at America's Table scale
Each reported frequency is expressed as a daily average ranging from 0 to 5. The estimate of the daily number of Pyramid/MyPyramid servings is calculated as average daily frequency x the number of Pyramid/MyPyramid servings for the portion size, summed across all food groups. A higher score for fruits and vegetables indicates a better outcome.
Measured: Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale
Eight items, each of which is scored 0 to 3, providing a 0 to 24 severity score. Overall score is the sum of the 8 items. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Measured: Baseline visit (W1) to week 16 visit
Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale
Values on the scale are: Strongly disagree, disagree, neutral, agree, and strongly agree. Responses of agree and strongly agree indicate a better outcome.
Measured: Baseline visit (W1) to 16-week visit
Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale
Six items, each of which is scored 0 to 10. Overall score is the mean of the 6 items. A higher score indicates a better outcome.
Measured: Baseline visit (W1) to 16-week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Akron General
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, The University of Akron
- Responsible party
- Sponsor
- Investigators
- Elliot B Davidson, MD, FAAFP, Principal investigator, Cleveland Clinic Akron General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174078
- Sponsor's protocol ID
- 21029
- Status last verified
- Aug 2024
- First submitted
- 1 Dec 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kibera PW, Ofei-Tenkorang NA, Mullen C, Lear AM, Davidson EB. Food as medicine: a quasi-randomized control trial of two healthy food interventions for chronic disease management among ambulatory patients at an urban academic center. Prim Health Care Res Dev. 2023 Dec 21;24:e72. doi: 10.1017/S1463423623000579.
PubMed 38126528
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
- ClinicalTrials.gov ID
- NCT05174078
- Acronym / sponsor ID
- 21029
- Conditions
- Obesity, Hypertension, Pre-diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cleveland Clinic Akron GeneralUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, The University of Akron
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 30 Dec 2021 (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 purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level.
The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.
Detailed description
Participants will receive healthy food items for 15 weeks and nutrition counseling and education to support chronic disease management at no cost. The healthy food items will consist of either medically-tailored pre-prepared meals, or a weekly produce box with recipes depending on the study arm. Participants must complete a baseline study visit, one nutritional counseling session via phone, 2 to 4 nutrition education videos, and a 16-week post-intervention study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A quasi-randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Medically-Tailored Meals (MTM) | Experimental | Other: Medically-tailored mealsMedically-tailored meals delivered to participants' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. |
| Produce Box and Recipes | Experimental | Other: Produce box and recipesWeekly produce box delivered to participants' homes and access to recipes via the internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. |
| Standard of Care | No intervention | –Matched controls from the same base population as participants in the intervention arms. Controls will identified from the electronic medical record (EMR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18 years of age or older who are patients at Akron General Center for Family Medicine
- Have body mass index (BMI) equal to or greater that 30kg/m2 AND
- Have at least one of the following diagnoses determined based on patients' problem list in the electronic medical record (EMR) and the international classification of diseases, 10th revision (ICD-10) codes:
- Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months
Key exclusion criteria (6 listed)
- Food allergies
- Pregnant
- No access to internet
- Need English language interpretation
- Currently participating in a structured weight loss program or using weight loss medications
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 |
|---|---|---|
| Medically-tailored mealsMedically tailored meals delivered to patients' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. | Other | Medically-Tailored Meals (MTM) |
| Produce box and recipesWeekly produce box and access to recipes via internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. | Other | Produce Box and Recipes |
Primary outcome
Change in participants' body weight
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Percent weight loss
13 secondary outcomes
Pre-type 2 diabetes mellitus: Change in number of medications
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Pre-type 2 diabetes mellitus: Change in medication dosage
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Pre-type 2 diabetes mellitus: Change in HbA1c
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in number of medications
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in medication dosage
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in HbA1c
Time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Hypertension: Change in number of medications
Time frame: Baseline visit (W1) to 16 week visit
Hypertension: Change in medication dosage
Time frame: Baseline visit (W1) to 16 week visit
Receipt of healthy food items: The Hunger Vital Sign scale
Time frame: Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Eating at America's Table scale
Time frame: Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale
Time frame: Baseline visit (W1) to week 16 visit
Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale
Time frame: Baseline visit (W1) to 16-week visit
Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale
Time frame: Baseline visit (W1) to 16-week visit
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 22 Aug 2024.
- Derived from this study: PubMed 38126528Kibera PW, Ofei-Tenkorang NA, Mullen C, Lear AM, Davidson EB. Food as medicine: a quasi-randomized control trial of two healthy food interventions for chronic disease management among ambulatory patients at an urban academic center. Prim Health Care Res Dev. 2023 Dec 21;24:e72. doi: 10.1017/S1463423623000579.
- 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.
Elliot B Davidson, MD, FAAFP principal investigator
Cleveland Clinic Akron General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically-tailored meals and Produce box and recipes in people with Obesity and Hypertension, run by Cleveland Clinic Akron General 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 7 inclusion and 6 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 22 Aug 2024. 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?
Change in participants' body weight (time frame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174078, which also lists 1 linked publication.
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 22 Aug 2024.