120 Participants NeededMy employer runs this trial

Family Diabetes Prevention for Weight Loss

(GA CEAL Trial)

KM
DM
Overseen ByDanielle M Duvernay, MSHI
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Morehouse School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a family-focused lifestyle program, called Family Diabetes Prevention, can reduce the risk of type 2 diabetes and promote healthy habits. The study will examine weight loss in parents and the role of family involvement in supporting these changes. It is open to African American or Hispanic families with parents who have prediabetes or are at risk, and children aged 12 to 17, provided all can participate in physical activities and commit to a 12-week program. As an unphased trial, participants can contribute to innovative research that may benefit their family's health and future generations.

What prior data suggests that this family-based lifestyle intervention is safe for participants?

Research has shown that family-based lifestyle programs are generally safe and easy for most people to follow. These programs, which focus on weight loss and diabetes prevention, have been found to lower the risk of developing type 2 diabetes without major safety issues. For instance, one study found that participants lost 5% to 7% of their body weight by eating fewer calories and exercising more, leading to a 58% reduction in the risk of developing type 2 diabetes.

Since these programs emphasize changes in diet and exercise, they typically don't involve medications or surgeries, reducing the risk of side effects. Participants often experience positive outcomes, such as better social support and healthier habits, without serious problems. Overall, these programs are considered safe for most people aiming to prevent diabetes and lose weight.12345

Why are researchers excited about this trial?

The Family Diabetes Prevention treatment is unique because it focuses on a holistic approach to diabetes prevention through family involvement and lifestyle changes, rather than solely relying on medication or insulin. Unlike traditional treatments that often emphasize individual dietary changes or medication management, this approach aims to create a supportive environment where family members participate together in healthier lifestyle choices. Researchers are excited because this method has the potential to not only improve individual health outcomes but also foster long-term habits that benefit entire families, making it a sustainable solution.

What evidence suggests that this family-based lifestyle intervention is effective for weight loss?

Research has shown that lifestyle changes can lower the risk of developing type 2 diabetes (T2D). In past studies, participants in similar programs lost about 5% of their body weight, significantly reducing their diabetes risk. Specifically, for every kilogram (about 2.2 pounds) of weight lost, the risk decreased by 16%. These programs typically aim for a 7% weight loss and encourage at least 150 minutes of exercise each week. Such changes have been shown to reduce the chance of developing diabetes by up to 58%. Overall, the evidence strongly supports that lifestyle changes can prevent T2D and promote healthy weight loss.15678

Who Is on the Research Team?

RC

Rakale C Quarells, PhD

Principal Investigator

Morehouse School of Medicine

Are You a Good Fit for This Trial?

This trial is for families with parents and children who are at risk for type 2 diabetes, such as those who are overweight or have prediabetes. Participants should be willing to join a family-based lifestyle program.

Inclusion Criteria

I am between 12 and 17 years old.
Parent/guardian must identify as African American or Hispanic
Parent/guardian must have no plans to move over the next 9 months
See 5 more

Exclusion Criteria

Participants currently pregnant or planning to become pregnant in the next year
Participants with co-morbid contraindications to physical activity or dietary changes
I am taking medications that could affect the study results.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants attend 12 weekly sessions focusing on lifestyle changes, including stress management, healthy eating, and physical activity

12 weeks
12 visits (in-person)

Follow-up

Participants are monitored for weight and lifestyle changes post-intervention

3 months
1 visit (in-person), electronic surveys

What Are the Treatments Tested in This Trial?

Interventions

  • Family Diabetes Prevention

Trial Overview

The study tests whether a family-focused lifestyle program can help parents lose weight and lower the risk of type 2 diabetes in both parents and children. Researchers will track changes in weight and healthy habits over about three months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single arm pre/post studyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Morehouse School of Medicine

Lead Sponsor

Trials
22
Recruited
16,300+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Diabetes Prevention, Weight Loss, and Social Support - PMC

A similar study has shown that clinically significant outcomes can be achieved in untreated family members of individuals undergoing a behavioral weight loss ...

Evidence

The intervention targeted a 7% reduction in body weight and at least 150 minutes of physical activity per week. It included individual coaching, ...

Weight loss and lifestyle change among high-risk ...

For every kilogram of weight loss, there was a 16% reduction in diabetes incidence (Hamman, 2006). Following this evidence, the Centers for Disease Control and ...

New Data from Diabetes Prevention Program Outcomes ...

The DPP demonstrated lifestyle intervention, aimed at achieving weight loss, and metformin treatment reduced the risk of T2D development by 58% ...

Evidence-Based Trends for Achieving Weight Loss and ...

The average weight loss with a diet-alone strategy was 20 lb, and the average decrease in glycated hemoglobin was 2.6 percentage points.12,13

Long-Term Safety, Tolerability, and Weight Loss Associated ...

In the Diabetes Prevention Program (DPP), metformin reduced the development of diabetes by 31% over an average of 2.8 years of follow-up (4,5).

Prevent Type 2 Diabetes: Talking to Your Patients About ...

58% lower incidence of type 2 diabetes after weight loss of 5 to 7% of body weight achieved by reducing calories and increasing physical ...

Diabetes prevention: 5 tips for taking control

Losing weight lowers the risk of diabetes. The American Diabetes Association recommends that people with prediabetes lose at least 5% to 7% of their body weight ...