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ObesityFFFIPGNCT01481948

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

A study testing Food, Fun, & Fitness Internet Program for Girls in people with Obesity, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 10 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Food, Fun, & Fitness Internet Program for Girls
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
1 siteUnited States
Study dates
Jan 2012to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 10 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 8-10 years old
  • healthy
  • African American
  • parent willing to participate in data collection
  • internet access
  • personal email address

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Food, Fun, & Fitness Internet Program for Girls
Keywords
physical activity, fruit and vegetable, water, girls, African American, online
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food, Fun, & Fitness Internet Program for GirlsBehavioural

    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.

Study groups in NCT01481948
Study groupRoleWhat they receive
story plus behaviorial proceduresExperimentalThe 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.
Receives: Behavioral: Food, Fun, & Fitness Internet Program for Girls
story onlyActive comparatorThe 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.
Receives: Behavioral: Food, Fun, & Fitness Internet Program for Girls
Wait list controlNo interventionThis group will participate in data collection only; after the 3rd data collection point, they will be given access to the intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass index percentile

    height and weight will be used to calculate BMI percentile

    Measured: 6 months

Secondary outcomes (10)

  1. fruit and vegetable consumption

    dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected (1 week day and 1 weekend day)

    Measured: 3 months

  2. physical activity

    Accelerometers will be used to assess physical activity at each time point

    Measured: 3 months

  3. self efficacy

    Standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy

    Measured: 3 months

  4. home availability

    standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability

    Measured: 3 months

  5. asking behaviors

    standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors

    Measured: 3 months

  6. fruit and vegetable consumption

    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)

    Measured: 6 months

  7. physical activity

    Accelerometers will be used to assess physical activity

    Measured: 6 months

  8. self efficacy

    standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy

    Measured: 6 months

  9. home availability

    standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability

    Measured: 6 months

  10. asking behaviors

    standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01481948
Sponsor's protocol ID
H-27505
Other IDs
R01MD005814
Acronym
FFFIPG
Status last verified
Jan 2016
First submitted
21 Nov 2011
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 28652960

  • 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.

    PubMed 23915235

Questions about this trial

What is this clinical trial studying?

A study testing Food, Fun, & Fitness Internet Program for Girls in people with Obesity, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index percentile (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01481948, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.

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