Food and Fitness Program for Type 2 Diabetes

(FFWM Trial)

Not yet recruiting at 2 trial locations

Overseen By Jade M Smith, MS, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must be taking: GLP-1RAs

Disqualifiers: Uncontrolled mental illness, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a program combining food, fitness, and medicine can help manage type 2 diabetes in post-menopausal women. Researchers aim to determine if this approach affects the continuation of a common diabetes medication and improves heart health scores. Participants will either receive a full support package, including groceries and fitness training, or access cooking demos. The trial seeks post-menopausal women with type 2 diabetes and stage 2 cardio-kidney metabolic syndrome who have recently started a specific diabetes medication.

As an unphased trial, this study offers participants a unique opportunity to contribute to innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on participants who have recently started a specific diabetes medication (GLP-1RAs), so you may need to continue that medication.

What prior data suggests that the Food and Fitness With Medicine (FFWM) program is safe for post-menopausal women with type-2 diabetes?

Research has shown that specially designed meal and food programs can assist people with diabetes. For instance, one study found that delivering meals tailored for diabetes patients improved their diet and facilitated access to healthy food. Participants reported no major side effects, indicating the program was well-received. Another study suggested that meeting food needs could enhance diabetes management, highlighting the safety and potential benefits of these programs.

While specific information on side effects from the Food and Fitness With Medicine (FFWM) program is not available, its combination of personalized meals, exercise, and education resembles other programs that have demonstrated positive results without major safety issues.

Overall, these programs appear safe and well-accepted, focusing on improving diet and lifestyle, which generally carry low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Food and Fitness With Medicine (FFWM) program for Type 2 Diabetes because it takes a holistic approach that combines medically tailored groceries, cooking classes, fitness training, and behavioral support. Unlike standard treatments that often focus primarily on medication, FFWM integrates lifestyle changes with medical care, aiming to improve overall health and diabetes management. This comprehensive program also provides participants with access to a secure web portal for ongoing support, setting it apart from traditional care options.

What evidence suggests that the Food and Fitness With Medicine program could be effective for type 2 diabetes?

Research has shown that combining specially prepared meals with exercise programs can improve diabetes management. In this trial, participants in the FFWM+ arm will receive medically tailored groceries, culinary training, fitness education, and behavioral reinforcers. One study found that providing these meals to people with diabetes improved their eating habits and access to healthy food. This method can also help stabilize blood sugar levels and may support weight loss. Additionally, diabetes medications such as semaglutide and tirzepatide have been shown to benefit heart health. Using these treatments together might enhance overall health for those with type 2 diabetes. ^{1 4 6 7 8}

Who Is on the Research Team?

Colleen K Spees, PhD, MEd, RD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

The FFWM trial is for post-menopausal women with stage 2 cardio-kidney metabolic syndrome and type-2 diabetes, who started on GLP-1RAs within the last 6 weeks. The study aims to help them manage their condition through lifestyle changes.

Inclusion Criteria

Access to an internet-enabled device

No objections to online grocery shopping, home food deliveries, or nutrition counseling

Residence meets Instacart delivery requirements (e.g., non-institutionalized)

Exclusion Criteria

I have not joined any nutrition programs or trials in the last 3 months.

Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or controlled through treatment, as determined by the study team

Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored groceries, culinary training, fitness education, and behavioral reinforcers for 24 weeks

24 weeks

Visits at 0, 12, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Food and Fitness With Medicine (FFWM)

Trial Overview This trial tests a combination of interventions: Exercise as Medicine (EIM), culinary education, a participant website, nutrition counseling, and Food is Medicine over a period of 24 weeks to see if they improve medication adherence and heart health scores.

How Is the Trial Designed?

Group I: FFWM+ Experimental Treatment 5 Interventions

Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.

Group II: Standard Care Active Control 1 Intervention

Control Group - access to optional cooking demos

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-8-2025-69a21

Food and Fitness Program for Type 2 Diabetes (FFWM Trial) The FFWM trial is for post-menopausal women with stage 2 cardio-kidney metabolic syndrome and type-2 diabetes, who started on GLP-1RAs within the last 6 weeks.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04828785

NCT04828785 | Food As MedicinE for Diabetes Food insecurity is a major contributor to disparities in diabetes outcomes. Medically tailored meal (MTM) delivery programs are a promising intervention for ...

3. news-medical.net news-medical.net/news/20251110/Diabetes-drugs-semaglutide-and-tirzepatide-show-real-world-heart-benefits.aspx

Diabetes drugs semaglutide and tirzepatide show real ... In real-world care, semaglutide lowered MACE compared with sitagliptin, and tirzepatide achieved cardiovascular effectiveness comparable to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12350580/

Effectiveness of Personalized Nutrition on Management ... Personalized nutrition shows promise in improving HbA1c, PPGR, and reducing carbohydrate intake, with potential effects on body weight, in ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2812982

Effect of an Intensive Food-as-Medicine Program on Health ... A randomized crossover study found that delivering medically tailored meals to patients with diabetes improved diet and food security, and a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07148713

Pilot of Continuous Glucose Monitor-Augmented Food Is ... This study is designed to test the feasibility and preliminary efficacy of a CGM-augmented FIM intervention for adults with type 2 diabetes and nutrition or ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9839527/

Medically Tailored Meals for Food Insecurity and Type 2 ... The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n=200) is a pragmatic trial with an active comparator.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352827324001101

Estimating the impact of addressing food needs on ... We estimated that not experiencing food needs may be associated with modestly better diabetes outcomes.