Clinical trial NCT01819493: Parents and Children Together Preventing Diabetes (PACT PD)
Official title: Parents and Children Together Preventing Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Keywords: Diabetes Prevention
Lifestyle Intervention
African American Families
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-03-27
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index
timeFrame: 12 weeks and 16 weeks.
Secondary outcomes:
measure: Waist Circumference
timeFrame: 12 weeks and 16 weeks.
measure: Physical activity
timeFrame: 12 weeks and 16 weeks
measure: Dietary Intake
timeFrame: 12 weeks and 16 weeks
measure: Blood Pressure
timeFrame: 12 weeks and 16 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Bettina Beech, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Edward Ip, PhD
role: PRINCIPAL_INVESTIGATOR
References: