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

NCT ID: NCT00563264

Last Updated: 2014-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

832 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Prevention & Control Postpartum Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

KAN-DO

Intervention Type 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.

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.

Group Type EXPERIMENTAL

KAN-DO

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* Medical conditions preventing mother from walking a mile without assistance
* Conditions preventing the child from regular activity
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Truls Ostbye, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Cheryl Lovelady, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Greensboro

Locations

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Duke University Dept. of Community and Family Medicine

Durham, North Carolina, United States

Site Status

UNC Greensboro

Greensboro, North Carolina, United States

Site Status

Countries

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United States

References

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Ostbye T, Zucker NL, Krause KM, Lovelady CA, Evenson KR, Peterson BL, Bastian LA, Swamy GK, West DG, Brouwer RJ. Kids and adults now! Defeat Obesity (KAN-DO): rationale, design and baseline characteristics. Contemp Clin Trials. 2011 May;32(3):461-9. doi: 10.1016/j.cct.2011.01.017. Epub 2011 Feb 18.

Reference Type BACKGROUND
PMID: 21300177 (View on PubMed)

Dolinsky DH, Brouwer RJ, Evenson KR, Siega-Riz AM, Ostbye T. Correlates of sedentary time and physical activity among preschool-aged children. Prev Chronic Dis. 2011 Nov;8(6):A131. Epub 2011 Oct 17.

Reference Type BACKGROUND
PMID: 22005624 (View on PubMed)

Wiltheiss GA, Lovelady CA, West DG, Brouwer RJ, Krause KM, Ostbye T. Diet quality and weight change among overweight and obese postpartum women enrolled in a behavioral intervention program. J Acad Nutr Diet. 2013 Jan;113(1):54-62. doi: 10.1016/j.jand.2012.08.012. Epub 2012 Nov 10.

Reference Type BACKGROUND
PMID: 23146549 (View on PubMed)

Ostbye T, Krause KM, Stroo M, Lovelady CA, Evenson KR, Peterson BL, Bastian LA, Swamy GK, West DG, Brouwer RJ, Zucker NL. Parent-focused change to prevent obesity in preschoolers: results from the KAN-DO study. Prev Med. 2012 Sep;55(3):188-95. doi: 10.1016/j.ypmed.2012.06.005. Epub 2012 Jun 13.

Reference Type RESULT
PMID: 22705016 (View on PubMed)

Ostbye T, Malhotra R, Stroo M, Lovelady C, Brouwer R, Zucker N, Fuemmeler B. The effect of the home environment on physical activity and dietary intake in preschool children. Int J Obes (Lond). 2013 Oct;37(10):1314-21. doi: 10.1038/ijo.2013.76. Epub 2013 May 20.

Reference Type DERIVED
PMID: 23736357 (View on PubMed)

Other Identifiers

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DK075439-01

Identifier Type: -

Identifier Source: secondary_id

8609

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00007666

Identifier Type: -

Identifier Source: org_study_id

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