NCT00563264

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
832

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 11, 2014

Status Verified

August 1, 2013

Enrollment Period

3.9 years

First QC Date

November 21, 2007

Last Update Submit

July 10, 2014

Conditions

Keywords

obesityparentingpostpartum periodfamily research

Outcome Measures

Primary Outcomes (1)

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

    ~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

    ~12 and ~24 months post baseline

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

EXPERIMENTAL

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

Interventions

KAN-DOBEHAVIORAL

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.

12

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Medical conditions preventing mother from walking a mile without assistance
  • Conditions preventing the child from regular activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Dept. of Community and Family Medicine

Durham, North Carolina, 27302, United States

Location

UNC Greensboro

Greensboro, North Carolina, 27402, United States

Location

Related Publications (5)

  • 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.

    PMID: 21300177BACKGROUND
  • 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.

    PMID: 22005624BACKGROUND
  • 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.

    PMID: 23146549BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Truls Ostbye, MD PhD

    Duke University

    PRINCIPAL INVESTIGATOR
  • Cheryl Lovelady, PhD, RD

    University of North Carolina, Greensboro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

July 11, 2014

Record last verified: 2013-08

Locations