NCT01481948

Brief Summary

The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction. This study will conduct an outcome evaluation to test short and longer term effects on obesity risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 21, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

3.3 years

First QC Date

November 21, 2011

Last Update Submit

January 18, 2016

Conditions

Keywords

physical activityfruit and vegetablewatergirlsAfrican Americanonline

Outcome Measures

Primary Outcomes (1)

  • Body mass index percentile

    height and weight will be used to calculate BMI percentile

    6 months

Secondary Outcomes (10)

  • fruit and vegetable consumption

    3 months

  • physical activity

    3 months

  • self efficacy

    3 months

  • home availability

    3 months

  • asking behaviors

    3 months

  • +5 more secondary outcomes

Study Arms (3)

story plus behaviorial procedures

EXPERIMENTAL

The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live. The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes. Girls randomized to this arm of the study will also engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.

Behavioral: Food, Fun, & Fitness Internet Program for Girls

story only

ACTIVE COMPARATOR

The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live. The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes. Girls randomized to this arm of the study will not engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.

Behavioral: Food, Fun, & Fitness Internet Program for Girls

Wait list control

NO INTERVENTION

This group will participate in data collection only; after the 3rd data collection point, they will be given access to the intervention

Interventions

This is an 8 episode intervention, delivered entirely over the internet. Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town. The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity. There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities. The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.

story onlystory plus behaviorial procedures

Eligibility Criteria

Age8 Years - 10 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • healthy
  • African American
  • parent willing to participate in data collection
  • internet access
  • personal email address

You may not qualify if:

  • mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection
  • taking medications that influence dietary behaviors, appetite, and/or physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Callender C, Liu Y, Moore CE, Thompson D. The baseline characteristics of parents and African American girls in an online obesity prevention program: A feasibility study. Prev Med Rep. 2017 May 19;7:110-115. doi: 10.1016/j.pmedr.2017.05.011. eCollection 2017 Sep.

  • Thompson D, Mahabir R, Bhatt R, Boutte C, Cantu D, Vazquez I, Callender C, Cullen K, Baranowski T, Liu Y, Walker C, Buday R. Butterfly Girls; promoting healthy diet and physical activity to young African American girls online: rationale and design. BMC Public Health. 2013 Aug 2;13:709. doi: 10.1186/1471-2458-13-709.

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Food

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Deborah I Thompson, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 30, 2011

Study Start

January 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations