Parents and Children Together Preventing Diabetes (PACT PD)

Diabetes Prevention Clinical Trial

— PACT PD  

Official title:

Parents and Children Together Preventing Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819493
• Other study ID #: IRB00021267
• Secondary ID: R34DK094108-01A1
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: April 16, 2015

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In response to the growing threat of obesity on the health of American children, specifically African American children, the investigators propose to develop a program to educate and motivate African American families to improve health behavior for obesity reduction and diabetes prevention. This project will be unique in its partnership with local YMCAs and its use of Family Health Coaches from the YMCAs who will work one-on-one with participating families. The investigators feel this program will benefit all members of the families who are enrolled and will encourage all members to participate though the study will target one parent and one child who is 8 to 10 years old.

Description:

The investigators' long-term research goal is to translate the Diabetes Prevention Program (DPP) in community-based settings for overweight/obese African American (AA) families at risk for Type 2 Diabetes Mellitus (T2DM). Intensive lifestyle approaches addressing physical activity, healthy eating patterns, and stress management are established methods for reducing obesity and risk of T2DM for adults (Knowler, 2002; Tuomilehto et al, 2001; Pan et al, 1997). But, minimal evidence exists that this knowledge has been translated in sustainable settings or in a manner that acknowledges the influences of daily life on motivation and family self-efficacy for changes in nutrition and physical activity. The study proposes to adapt these components for AA families through the use of "family coaches", one-on-one intervention sessions through supervised individualized physical activity, and tailoring intervention strategies for individual families. Utilizing a family systems approach, each component will be delivered using brief motivational strategies that will target self-efficacy and motivational readiness. This four month, two-arm randomized clinical trial, Parents and Children Together Preventing Diabetes (PACT PD) will test the central hypothesis that, relative to a control condition, a "family health coaching" intervention focused on nutrition and physical activity using brief motivational strategies will improve targeted dietary and physical activity behaviors in overweight/obese AA parents and their overweight/obese 8-10 year old children, (N=50 families) all of whom are at risk for T2DM diabetes. This study will test the feasibility and acceptability of training YMCA fitness staff to utilize brief motivational interviewing and serve as "family health coaches". This study will evaluate the early efficacy of the newly translated, family-based diabetes prevention intervention in improving anthropometric measures of BMI (primary outcome) and waist circumference, physical activity and dietary intake, and family functioning (secondary outcomes) and intervention fidelity, feasibility and acceptability of participants. Further, the study will assess the acceptability and feasibility of booster interventions for motivation maintenance and potential for long-term retention and intervention success in the subsequent R18 application. This study will provide critical information regarding the early effectiveness of an innovative, family-based, behavioral intervention for the prevention of T2DM specifically translated for AA families. This study is funded by the National Institutes for Diabetes and Digestive and Kidney Disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 16, 2015
• Est. primary completion date: April 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Body Mass index (One overweight/obese parent (25 kg/m2 <BMI<40 kg/m2 and one overweight/obese child (at or above the 85th% of age-and gender- specific BMI)

• Parental HbA1c levels (pre-diabetes = 5.7 - 6.4%)

• Parent and their child age 8-10

Exclusion Criteria:

• Clinical history of T2DM

• On glucose-lowering drugs

• Currently participating in a supervised weight loss program

• Pregnant or Breastfeeding

• Has conditions limiting participation in the interventions

• Has undergone weight loss surgery

• Unwilling to accept randomization

• Plans to live outside the general area in the next 6 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Prevention

Intervention

Behavioral:
• Lifestyle Intervention
Family-based group lifestyle intervention
• Standard Family-Based intervention
Comparison intervention

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index	The study will assess change in body mass index in both parents and children at 2 post-randomization time points. We will compare these with baseline BMI.	12 weeks and 16 weeks.
Secondary	Waist Circumference		12 weeks and 16 weeks.
Secondary	Physical activity	The study will measure physical activity in parents and children by accelerometry.	12 weeks and 16 weeks
Secondary	Dietary Intake	The study will use BLOCK measures for both children and parents to assess dietary intake.	12 weeks and 16 weeks
Secondary	Blood Pressure		12 weeks and 16 weeks