- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481948
Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation (FFFIPG)
January 18, 2016 updated by: Deborah Thompson, Baylor College of Medicine
Using Technology to Prevent Obesity Among African American Girls
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old African American girls.
A pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were < 10%; logon rates to the online program were 74.5%; and statistically significant increases in fruit and vegetable consumption and time spent being physically active were observed.
The outcome evaluation will recruit 400 child-parent pairs to examine short and longer term effects of the program on obesity risk.
It will also conduct mediation analyses to examine pathways of effect.
At the end of the study, the web based program will be hosted on the CNRC web site.
Although the use of the internet as a method for changing health behavior is not new, the use of an internet program alone, with no face to face interaction, is novel.
This is one of the first programs to attempt this, particularly in an at-risk population.
Study Type
Interventional
Enrollment (Actual)
342
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 8-10 years old
- healthy
- African American
- parent willing to participate in data collection
- internet access
- personal email address
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: story plus behaviorial procedures
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.
|
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.
|
|
Active Comparator: story only
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.
|
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.
|
|
No Intervention: Wait list control
This group will participate in data collection only; after the 3rd data collection point, they will be given access to the intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index percentile
Time Frame: 6 months
|
height and weight will be used to calculate BMI percentile
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fruit and vegetable consumption
Time Frame: 3 months
|
dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected (1 week day and 1 weekend day)
|
3 months
|
|
physical activity
Time Frame: 3 months
|
Accelerometers will be used to assess physical activity at each time point
|
3 months
|
|
self efficacy
Time Frame: 3 months
|
Standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
3 months
|
|
home availability
Time Frame: 3 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
3 months
|
|
asking behaviors
Time Frame: 3 months
|
standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
|
3 months
|
|
fruit and vegetable consumption
Time Frame: 6 months
|
dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected at each time point (1 week day and 1 weekend day)
|
6 months
|
|
physical activity
Time Frame: 6 months
|
Accelerometers will be used to assess physical activity
|
6 months
|
|
self efficacy
Time Frame: 6 months
|
standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
6 months
|
|
home availability
Time Frame: 6 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
6 months
|
|
asking behaviors
Time Frame: 6 months
|
standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deborah I Thompson, PhD, Baylor College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 28, 2011
First Posted (Estimate)
November 30, 2011
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 18, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-27505
- R01MD005814 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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