KAN-DO: A Family-based Intervention to Prevent Childhood Obesity (KAN-DO)

July 10, 2014 updated by: Duke University
The purpose of this study is to evaluate the efficacy of an intervention (KAN-DO: Kids & Adults Now - Defeat Obesity) encouraging postpartum mothers and their preschool-aged children to work together to promote healthy eating, increase physical activity, and reduce sedentary behaviors. Via instruction in parenting skills and behavior change strategies, the goal is relative weight maintenance in children of healthy weight, and relative weight reduction in overweight children. The intervention will focus on a child (2-5 years of age) and his or her overweight or obese mother, who has just delivered a second or subsequent baby.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OVERVIEW

The purpose of the study is to evaluate the efficacy of an intervention encouraging postpartum mothers and their preschool-aged children to work together to promote healthy eating, increase physical activity, and reduce sedentary behaviors. Via instruction in parenting skills and behavior change strategies, the end goal is relative weight maintenance in children of healthy weight, and relative weight reduction in overweight children. The intervention will focus on a preschooler (2-5 years of age) and his or her overweight or obese mother, who has just delivered a second or subsequent baby. 400 mother/preschooler dyads from the Triad and Triangle areas of NC will be randomized to:

THE CONTROL ARM Mothers in the control arm will receive a monthly newsletter, and be given monetary incentives to complete the baseline and follow-up assessments; or

THE KAN-DO INTERVENTION ARM Mothers and preschoolers in the intervention group will receive monthly mailed family kits that encourage interactive mother/child exercises for healthy lifestyle change. Mailings are supported by counseling calls and two in-person motivational/informational group sessions. The content of the intervention addresses parenting skills, healthy eating, and physical activity. Families can earn $40 for returning postcards describing their activities in the past month.

PRIMARY AIMS of the study address weight and behavior change in the child. SECONDARY AIMS of the study address expected healthy changes in the mother. Further, we will investigate the roles of parenting skills.

RECRUITMENT Eligible households contain a woman with a current postpartum BMI > 25 who has delivered a child in the past 6 months, and who has another child between the ages of 2 and 5.

SCREENING AND ELIGIBILITY:

At ~6 weeks postpartum, all women will be contacted by study staff and will have the study fully described. If women are interested, they will complete a brief set of questions to assess eligibility criteria, including: recent delivery of a baby, a preschooler in the home (2-5 years old), and a current BMI ≥25 (a confirmatory BMI ≥25 measured at baseline will be required for final inclusion). As part of the screening interview, women will also be asked questions to determine if either mother or preschooler has any conditions that would exclude them medically from the study. Eligible and interested families will be told that their family will be assigned at random to one of the research groups.

CONSENT:

Mother/child dyads that are deemed eligible and are willing to participate will attend a personal consent and baseline data collection appointment either at the Duke or UNC-G site. Women will bring their 2-5 year old child to this appointment. Consenting families will complete a survey, be weighed and measured, wear an activity monitor for a week and complete a dietary recall over the phone.

FOLLOW-UP Mother/child dyads will be contacted again at 12 and 24 months postpartum for final assessments. The 12 assessments are similar in scope to the baseline visit.

Study Type

Interventional

Enrollment (Actual)

832

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27302
        • Duke University Dept. of Community and Family Medicine
      • Greensboro, North Carolina, United States, 27402
        • UNC Greensboro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recent delivery of a baby (~6 months ago)
  • A preschooler in the home (2-5 years old), and a current BMI ≥25 (with confirmatory BMI ≥25 measured at baseline
  • Knowledge of English
  • Regular access to a telephone and mailing address
  • Mother's age of 18 or older
  • Willingness to participate in a healthy lifestyle correspondence and telephone intervention.

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Medical conditions preventing mother from walking a mile without assistance
  • Conditions preventing the child from regular activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Participants receive monthly newsletter (for 10 months) including general health and reading information for child and mother and incentives for completing the baseline and 2 follow-up assessments
Behavioral: KAN-DO

The 10 month KAN-DO intervention includes eight mailed interactive activity modules involving both the preschooler and mother that include relevant printed materials emphasizing parenting skills, healthy eating habits and increased physical activity. Mailed kits will each be followed by a supportive telephone counseling session based on motivational interviewing techniques. Mailed modules and telephone calls will be supplemented with two in-person motivational and informational sessions (at the beginning and in the middle of the intervention period).

The Active Comparator group will receive monthly newsletters over the 10 month period related to boosting reading skills in their preschool children.
Experimental: 2
Mothers and preschoolers in the intervention group will receive monthly mailed family kits that encourage interactive mother/child exercises for healthy lifestyle change. Mailings are supported by counseling calls and two in-person motivational/informational group sessions. The content of the intervention addresses parenting skills, healthy eating, and physical activity. Families can earn $40 for returning postcards describing their activities in the past month.
Behavioral: KAN-DO

The 10 month KAN-DO intervention includes eight mailed interactive activity modules involving both the preschooler and mother that include relevant printed materials emphasizing parenting skills, healthy eating habits and increased physical activity. Mailed kits will each be followed by a supportive telephone counseling session based on motivational interviewing techniques. Mailed modules and telephone calls will be supplemented with two in-person motivational and informational sessions (at the beginning and in the middle of the intervention period).

The Active Comparator group will receive monthly newsletters over the 10 month period related to boosting reading skills in their preschool children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI z-score (via measured weight and height) of preschooler
Time Frame: ~2 years post baseline
~2 years post baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Mother's measured weight, as well as eating and physical activity behavioral targets (brief measures) in both mother and child
Time Frame: ~12 and ~24 months post baseline
~12 and ~24 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

  • Principal Investigator: Truls Ostbye, MD PhD, Duke University
  • Principal Investigator: Cheryl Lovelady, PhD, RD, University of North Carolina, Greensboro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00007666
  • DK075439-01
  • 8609 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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