NCT01358448

Brief Summary

In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2011

Typical duration 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

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

May 17, 2011

Last Update Submit

April 3, 2018

Conditions

Obesity

Keywords

Treatment of childhood obesity

Outcome Measures

Primary Outcomes (4)

  • Weight Status

    BMI z-score

    Baseline and 6-month

  • Dietary Intake

    dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)

    baseline and 6-months

  • Leisure-time Behaviors

    leisure-time behaviors (moderate-intense physical activity and television viewing)

    Baseline and 6-months

  • Caretaker Feeding Behaviors

    Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires

    Baseline and 6-months

Secondary Outcomes (1)

  • Cost Effectiveness

    6-months

Study Arms (3)

Newsletter

NO INTERVENTION

Growth Monitoring

EXPERIMENTAL
Behavioral: growth monitoring

Growth Monitoring plus Family-based Behavioral Counseling

EXPERIMENTAL
Behavioral: Growth Monitoring plus Family-based Behavioral Counseling

Interventions

growth monitoringBEHAVIORAL

Caretakers will be encouraged to monitor child growth monthly.

Growth Monitoring
Growth Monitoring plus Family-based Behavioral CounselingBEHAVIORAL

Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling

Growth Monitoring plus Family-based Behavioral Counseling

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • between 4 to 8 years of age at the start of the intervention
  • overweight or obese (≥85th BMI-for-age percentile)
  • have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
  • not currently participating in a weight loss program and/or taking weight loss medication
  • have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
  • caretaker must be able to read, speak and understand English and the child speak English
  • have transportation to their child's primary care provider office
  • family does not plan to move out of the area before March 2012

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Knoxville Pediatric Associates

Knoxville, Tennessee, 37923, United States

Location

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 23, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(2)