Trials / Completed
CompletedNCT01809795
The Health Effects of a Blueberry Enriched Diet on Obese Children
The Health Effects of a Blueberry Enriched Diet on Obese Children: A Feasibility Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study to determine if adding blueberries to obese children's diet will improve weight status and other medical testing. We would also like to determine if a larger research study involving blueberries is possible.
Detailed description
Ten children aged 12 to 17 years of age who have a BMI \> 95th percentile for age and who are patients of the Center for Better Health and Nutrition will be recruited for this 12 week study. Group 1 (Standard Therapy): Participants will be asked not to consume berries during the study so as not to confound the effects of eating blueberries. They will, however, be encouraged to consume other fruits consistent with nutrition guidelines for the Healthy Eating Plan (HEP: reduced glycemic load diet). Participants will be instructed and receive educational handout materials on implementing HEP. In addition participants will be introduced to the use of behavioral tools (e.g. goal setting, daily tracking when goals are met, and incentives provided by the family) to help them stay on track with HEP. Participants will be seen by the dietitian at monthly intervals consistent with programmatic standard of care to review adherence to HEP, use of behavioral tools, and change in weight status. Participants will be encouraged to attend group exercise classes five days per week or a minimum of four days per week. At the end of each exercise session, participants will receive a "sham smoothie" which contains no blueberries. The children will be directly observed by a study worker when consuming the smoothies to ensure compliance and measure how much of the smoothie was consumed. Group 2 (Blueberry Enhanced): All the features of Group 1 with the exception that the participants will be given a smoothie that contain 1 1/2 cups of freeze-dried whole blueberries crushed into a powder per serving.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Blueberry Smoothie | |
| OTHER | Sham Smoothie |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2013-10-01
- Completion
- 2014-12-01
- First posted
- 2013-03-13
- Last updated
- 2014-12-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01809795. Inclusion in this directory is not an endorsement.