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Completed

NCT Number: NCT01819493

Parents and Children Together Preventing Diabetes (PACT PD)

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.

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Key information

Conditions

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

Family-based group lifestyle intervention

Standard Family-Based intervention

Behavioral

Comparison intervention

Primary outcomes

  1. Body Mass Index

    Time frame: 12 weeks and 16 weeks.

    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.

Secondary outcomes

  1. Waist Circumference

    Time frame: 12 weeks and 16 weeks.

  2. Physical activity

    Time frame: 12 weeks and 16 weeks

    The study will measure physical activity in parents and children by accelerometry.

  3. Dietary Intake

    Time frame: 12 weeks and 16 weeks

    The study will use BLOCK measures for both children and parents to assess dietary intake.

  4. Blood Pressure

    Time frame: 12 weeks and 16 weeks

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Parents and Children Together Preventing Diabetes

Acronym: PACT PD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2013
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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