Clinical trial NCT05174078: Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
Official title: Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Pre-diabetes
Type 2 Diabetes
Lead sponsor: Cleveland Clinic Akron General
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: The University of Akron
First posted: 2021-12-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A quasi-randomized control trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Pre-type 2 diabetes mellitus
  2. Type 2 diabetes mellitus
  3. Hypertension
* Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in participants' body weight
timeFrame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Secondary outcomes:
measure: Pre-type 2 diabetes mellitus: Change in number of medications
timeFrame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
measure: Pre-type 2 diabetes mellitus: Change in medication dosage
timeFrame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
measure: Pre-type 2 diabetes mellitus: Change in HbA1c
timeFrame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
measure: Type 2 diabetes mellitus: Change in number of medications
timeFrame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
measure: Type 2 diabetes mellitus: Change in medication dosage
timeFrame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
measure: Type 2 diabetes mellitus: Change in HbA1c
timeFrame: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
measure: Hypertension: Change in number of medications
timeFrame: Baseline visit (W1) to 16 week visit
measure: Hypertension: Change in medication dosage
timeFrame: Baseline visit (W1) to 16 week visit
measure: Receipt of healthy food items: The Hunger Vital Sign scale
timeFrame: Baseline visit (W1) to week 16 visit
measure: Receipt of healthy food items: Eating at America's Table scale
timeFrame: Baseline visit (W1) to week 16 visit
measure: Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale
timeFrame: Baseline visit (W1) to week 16 visit
measure: Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale
timeFrame: Baseline visit (W1) to 16-week visit
measure: Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale
timeFrame: Baseline visit (W1) to 16-week visit
Other outcomes:
Locations:
city: Akron
country: United States
facility: Cleveland Clinic Akron General
state: Ohio
Study officials:
affiliation: Cleveland Clinic Akron General
name: Elliot B Davidson, MD, FAAFP
role: PRINCIPAL_INVESTIGATOR
References: