Obesity Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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