Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation (FFFIPG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Baylor College of Medicine
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 20, 2014