A Trial of Two Family-based Childhood Obesity Treatment Programs
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ClinicalTrials.gov Identifier: NCT03245775 |
Recruitment Status : Unknown
Verified August 2017 by Jamie Zoellner, PhD RD, University of Virginia.
Recruitment status was: Recruiting
First Posted : August 10, 2017
Last Update Posted : August 11, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity, Childhood | Behavioral: iChoose Behavioral: Family Connections | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 348 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized-controlled Trial to Compare the Reach, Effectiveness and Maintenance of Two Family-based Childhood Obesity Treatment Programs in a Medically Underserved Region |
Actual Study Start Date : | June 1, 2017 |
Estimated Primary Completion Date : | November 30, 2019 |
Estimated Study Completion Date : | May 29, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: iChoose
12 bi-weekly sessions & 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only
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Behavioral: iChoose
12 bi-weekly sessions & 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only |
Experimental: Family Connections
2 in-person sessions spaced one week apart & 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
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Behavioral: Family Connections
2 in-person sessions spaced one week apart & 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only |
- child BMI z-score [ Time Frame: 6-months ]
- parent BMI [ Time Frame: 6-month ]
- child self-reported diet, physical activity, quality of life, health literacy [ Time Frame: 6-months ]
- child self-reported diet, physical activity, quality of life, health literacy, home environment [ Time Frame: 6-months ]

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Ages Eligible for Study: | 8 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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Parent/child dyads will be eligible for participation if they reside in the Dan River Region
- English speaking
- child with a BMI percentile ranking of 85 or higher
Exclusion Criteria:
- children with a major cognitive impairment and parents or children with a medical contraindication for moderate physical activity.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245775
Contact: Jamie M Zoellner, PhD, RD | 434-962-4488 | jz9q@virginia.edu | |
Contact: Paul A Estabrooks, PhD | 402.559.4325 | Paul.estabrooks@unmc.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908-0717 | |
Contact: Jamie M Zoellner, PhD 434-962-4488 jz9q@virginia.edu |
Responsible Party: | Jamie Zoellner, PhD RD, Associate Professor, University of Virginia |
ClinicalTrials.gov Identifier: | NCT03245775 |
Other Study ID Numbers: |
19748 |
First Posted: | August 10, 2017 Key Record Dates |
Last Update Posted: | August 11, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
health disparities community-based participatory research |
Obesity Pediatric Obesity Overnutrition |
Nutrition Disorders Overweight Body Weight |