Prevention of Childhood Obesity

Obesity Clinical Trial

Official title:

The Development of an Early Intervention for the Prevention of Childhood Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788203
• Other study ID #: SU-11052008-1335
• Secondary ID: R21HD055637
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2008
• Last updated: July 21, 2011
• Start date: August 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. If the education program can change parental behavior the next study would examine whether this affects children's weight over a longer period of time.

Description:

There are two main studies in this project. For both studies families with a child between 2 and 4-years will be entered to the study although only the parents will participate. At least one parent will be overweight with a BMI>27.5, and the child will have a reactive temperament assessed by the Children's Behavior Questionnaire (CBQ) completed by the parent with a combined score on the approach/impulsivity scales of 4.65 (possible range 1 - 7). The cut-points for parental BMI and their child's temperament derive from our previous prospective risk factor study. Screening will consist of a brief telephone screen to ascertain willingness to participate in further screening and self-reported BMI. Both parents will be invited to the laboratory to ascertain whether they meet BMI criteria. In Study 1 parents with a child with either reactive or non-reactive temperament patterns will be entered to this study. In Study 2 only parents with a child with a reactive temperament will be admitted to the study. There will be no randomization in Study 1. There will also be 2 focus groups each lasting 90-minutes to ascertain typical child feeding problems, and a pilot administration of the interventions. In Study 2 parents will be randomized to receive either the experimental intervention or a health education program aimed at enhancing their children's health. Each group session will last 90-minutes and there will be 10 group sessions at weekly intervals. Assessments in both studies will be similar and will consist of questionnaires aimed at assessing family and children's feeding behaviors and parental attitudes and behaviors concerning their own weight/shape and dieting. We estimate that the assessments will take approximately 60-minutes to complete in Study 1 and 45-minutes each in Study 2 because extraneous questions will be removed as a result of findings in Study 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria:

For study 1, 60 families (120 parents) with a child between the age of 2-4 years will be entered to the study. Children of these families will be at risk for overweight because the family will contain at least one obese parent. For study 2, 100 families (200 parents) will be entered to the study. Children of these families will be at risk for overweight and have a reactive temperament. The reason for using this population is that a combination of parental obesity and a child with a reactive temperament appears to put the child at high risk for the development of overweight.

Exclusion Criteria:Parental exclusions:

1. Not able to comprehend English well enough to participate in assessments or the intervention.

2. Serious non-obesity related physical illness, (e.g., cancer), which would preclude participation in assessment or intervention.

3. Serious current psychiatric disorder, e.g. schizophrenia, uncontrolled bipolar disorder, mental retardation that would preclude participation in assessment or intervention.

4. Single parents

Child exclusions:

1. Serious physical illness or related treatments that would affect feeding or weight including history of feeding aversion, failure to thrive, and use of nasogastric or gastrostomy feeding.

2. Prematurity below 37-weeks associated with prolonged hospitalization, ongoing need for nutritional supplementation, or naso-gastric feeding.(parental report)

3. Serious current developmental problems including any that might interfere with self-feeding or require additional parental feeding support e.g. developmental delay, autism. (parental report).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental restraint concerning eating		Prospective	No
Secondary	Daily eating pattern	Parental report of feeding frequency	Weekly	No