Families Implementing Good Health Traditions for Life

Overview

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

Detailed description

The goal of this project is to utilize a community-engaged research approach to reduce type 2 diabetes risk among Black families through the tailoring of the diabetes prevention program for families. The proposed study will be carried out by researchers and community members with expertise in community engagement, type 2 diabetes prevention, and family interventions/programming. It is hypothesized that the Families Implementing Good Health Traditions for Life study (FIGHT for Life), a region specific adaptation of the Diabetes Prevention Program (DPP) for high-risk adults paired with a DPP-adapted curriculum for children will result in improved program acceptance and compliance, thus improving health indicators associated with type 2 diabetes risk across Black families. The efficacy of the community-engaged research-adapted FIGHT for Life intervention to improve weight, an important type 2 diabetes risk factor, in Black parents with pre-diabetes (primary outcome) will be evaluated. The goal is that parents enrolled in the family intervention will demonstrate a 4% reduction in weight at the end of the intervention.

Interventions

• Behavioral Families Implementing Good Health Traditions for Life
  The 16-session weekly curriculum will have five components: 1) strategies for monitoring food intake and reducing calories; 2) identifying and controlling both personal and social cues for unhealthy eating behaviors; 3) the role of stress in unhealthy eating and relapse prevention; 4) strategies for monitoring and improving physical activity and sedentary behaviors; and 5) strategies to improve family support and cohesion. Parents and children will be divided into separate, 2-hour sessions most

Primary outcome measures

• Change in weight from baseline to post-intervention at 4 months [Time frame: 4 months]

Eligibility criteria

Inclusion criteria

• Family 1.a.) Black Parent/Guardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old
• Parent/Guardian have HbA1c level 5.7-6.4% (prediabetes)
• Parent/Guardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months
• Parent/child are ambulatory and able to participate in physical activity

Exclusion criteria

• Individuals with severe psychological disorders that may prevent/interfere with study participation
• Physical impairments that may prevent participation in moderate intensity physical activity;
• Previous diagnosis of diabetes
• History of congestive heart failure, renal failure, or recent (<12 months) cardiovascular events such as myocardial infarction or stroke;
• Person taking medications that may affect endpoint analyses
• Persons with co-morbid contraindications to physical activity or dietary changes.
• Currently pregnant or planning to become pregnant in the next year.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Morehouse School of Medicine — Albany

Identifiers

NCT: NCT07441655 · 2022805-14 · 2U54MD007602-36

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗