NCT01819493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2015

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

March 22, 2013

Last Update Submit

August 13, 2018

Conditions

Diabetes Prevention

Keywords

Diabetes PreventionLifestyle InterventionAfrican American Families

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Waist Circumference

    12 weeks and 16 weeks.

  • Physical activity

    12 weeks and 16 weeks

  • Dietary Intake

    12 weeks and 16 weeks

  • Blood Pressure

    12 weeks and 16 weeks

Study Arms (2)

Standard Family-Based intervention

ACTIVE COMPARATOR

Families randomized to the Standard Family-based Intervention will receive three-month family YMCA memberships, one orientation training session, access to available equipment and programming at the YMCA, and receive diabetes educational materials from the "Power to Prevent" curriculum via email. Based on our previous experience with AA adults, the investigators anticipate that all families will have access to email either at home or at work. Educational materials will be mailed to families without access to email. The study will also maintain contact with participants by sending holiday and birthday cards, as well as postcard reminders of scheduled data collection visits.

Behavioral: Standard Family-Based intervention

Lifestyle Intervention

EXPERIMENTAL

The lifestyle intervention for adults will involve a dietary weight loss program and an increase in caloric expenditure through moderate PA. Parents will be encouraged to decrease caloric intake in a sound manner to produce a total weight loss of 5%. The PA component will be to promote an increase in family home-based activity. Children. The study will promote healthy eating behaviors, rather than restrictive eating plans with caloric restrictions.

Behavioral: Lifestyle Intervention

Interventions

Lifestyle InterventionBEHAVIORAL

Family-based group lifestyle intervention

Lifestyle Intervention
Standard Family-Based interventionBEHAVIORAL

Comparison intervention

Standard Family-Based intervention

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

  • Bettina Beech, DrPH

    Wake Forest University

    PRINCIPAL INVESTIGATOR

  • Edward Ip, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

April 16, 2015

Study Completion

April 16, 2015

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(1)