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Completed

NCT Number: NCT00563264

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

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Dept. of Community and Family Medicine, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

KAN-DO

Behavioral

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.

Primary outcomes

  1. BMI z-score (via measured weight and height) of preschooler

    Time frame: ~2 years post baseline

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Acronym: KAN-DO

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 26, 2007
Registry last updated
Jul 11, 2014

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

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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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