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

NCT ID: NCT01481948

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-05-31

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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Food, Fun, & Fitness Internet Program for Girls

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Food, Fun, & Fitness Internet Program for Girls

Intervention Type: BEHAVIORAL

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Deborah Thompson

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah I Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28652960 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23915235 (View on PubMed)

Other Identifiers

R01MD005814

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-27505

Identifier Type: -

Identifier Source: org_study_id