Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation (FFFIPG)
This study is currently recruiting participants.
Verified April 2013 by Baylor College of Medicine
Sponsor:
Baylor College of Medicine
Collaborator:
Information provided by (Responsible Party):
Deborah Thompson, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01481948
First received: November 21, 2011
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Food, Fun, & Fitness Internet Program for Girls |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Using Technology to Prevent Obesity Among African American Girls |
Resource links provided by NLM:
Further study details as provided by Baylor College of Medicine:
Primary Outcome Measures:
- Body mass index percentile [ Time Frame: 6 months ] [ Designated as safety issue: No ]height and weight will be used to calculate BMI percentile
Secondary Outcome Measures:
- fruit and vegetable consumption [ Time Frame: 3 months ] [ Designated as safety issue: No ]dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected (1 week day and 1 weekend day)
- physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]Accelerometers will be used to assess physical activity at each time point
- self efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]Standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
- home availability [ Time Frame: 3 months ] [ Designated as safety issue: No ]standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
- asking behaviors [ Time Frame: 3 months ] [ Designated as safety issue: No ]standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
- fruit and vegetable consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]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)
- physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Accelerometers will be used to assess physical activity
- self efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
- home availability [ Time Frame: 6 months ] [ Designated as safety issue: No ]standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
- asking behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
| Estimated Enrollment: | 800 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: Food, Fun, & Fitness Internet Program for Girls
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.
|
Behavioral: Food, Fun, & Fitness Internet Program for Girls
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
|
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.
Eligibility| Ages Eligible for Study: | 8 Years to 10 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481948
Locations
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Marilynn Navarrete 713-798-7002 rilynn@bcm.edu | |
| Contact: Chishinga Callender 713-798-0506 Chishinga.Callender@bcm.edu | |
| Principal Investigator: Deborah Thompson, PhD | |
| Sub-Investigator: Tom Baranowski, PhD | |
| Sub-Investigator: Karen Cullen, DrPH | |
Sponsors and Collaborators
Baylor College of Medicine
Investigators
| Principal Investigator: | Deborah I Thompson, PhD | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | Deborah Thompson, Assistant Professor of Pediatrics, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01481948 History of Changes |
| Other Study ID Numbers: | H-27505, R01MD005814 |
| Study First Received: | November 21, 2011 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Baylor College of Medicine:
|
physical activity fruit and vegetable water |
girls African American online |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013