ObesityCHOICESNCT01674920
CHOICES: Family Physicians Treat Overweight Children
A study testing Choices in people with Obesity and Overweight, run by University of Arizona at 1 site in United States.
Trial summary
CHOICES is a program to provide children and families with lifetime tools and lifestyle strategies to achieve and maintain a healthy body size. Both parents and children get active, learn about the food choices they can make, and about the roles of TV in their lives. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Choices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2008
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.
Who cannot join
- Conditions that would preclude dietary change or physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
CHOICES is a program to provide children and families with lifetime tools and lifestyle strategies to achieve and maintain a healthy body size. Both parents and children get active, learn about the food choices they can make, and about the roles of TV in their lives. Led by physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences that connect into the participants' daily lives. In the study, the families were divided into two groups, beginning their classes 6 months apart. Body measurements were taken at baseline and every 4 months to 16 months.
Read the detailed description
The specific aim of this pilot study was to use the group office visit model to provide an obesity treatment intervention for children 8-11 years of age in gender-specific groups and their parents in a clinic setting. The targeted lifestyle components of the intervention are less TV viewing, less sweetened beverages, smaller food portions, less fast food/better choices away from home and more general physical activity. The psychosocial component was based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in relation to personal goals and knowledge of the basics of nutrition and physical activity.
Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and their parents for a 12 weekly sessions group office visit program. Participants were randomized into 2 groups; one group starting in March 2006 and the lagged intervention control group starting in September 2006. Physical measurements and data collection were at baseline, 4, 8, 12, 16 months from randomization.
We evaluated the acceptability and feasibility of the group office visit model and effect size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability included ability to recruit within clinics, attendance, completion, follow-up rates, focus groups data and interviews of those who drop out. Evaluation of effect size included the patterns of growth over 15 months from baseline in relation to expected growth patterns and intervention exposure.
- Conditions
- Obesity, Overweight
- Being tested
- Choices
- Keywords
- Pediatric obesity, resiliency, physical activity, dietary patterns, children
- Medical subject headings
- Obesity, Overweight, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChoicesBehavioural
Also called Resiliency, Nutrition, Physical Activity
The 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.
| Study group | Role | What they receive |
|---|---|---|
| Choices | Experimental | The 3-month twelve-session intervention, "Choices", included topics on nutrition, physical activity, and resiliency. Parents, boys and girls met separately. The sessions were developed for delivery by a family physician, two family medicine residents, and a nutritionist, who received training in positive psychology and resilience skills. All children were measured on the same dates, but children were randomly assigned to two cohorts, beginning 6 months apart, to facilitate statistical analysis by having one group experience "normal growth" on study prior to intervention. Receives: Behavioral: Choices |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index age-and-gender specific Z-score
body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units. It is used to control for growth effects in children.
Measured: 9 months post intervention baseline
Secondary outcomes (1)
weight for age-and-gender specific Z-score
Measured: 9 months post-intervention baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startJan 2006
- Primary completionJun 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Cheryl K Ritenbaugh, PhD, MPH, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674920
- Sponsor's protocol ID
- 1R21HD050962
- Other IDs
- 1R21HD050962
- Acronym
- CHOICES
- Status last verified
- Aug 2012
- First submitted
- 18 May 2008
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOICES: Family Physicians Treat Overweight Children
- ClinicalTrials.gov ID
- NCT01674920
- Acronym / sponsor ID
- CHOICES / 1R21HD050962
- Conditions
- Obesity, Overweight
- Keywords
- Pediatric obesity, resiliency, physical activity, dietary patterns, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CHOICES is a program to provide children and families with lifetime tools and lifestyle strategies to achieve and maintain a healthy body size. Both parents and children get active, learn about the food choices they can make, and about the roles of TV in their lives. Led by physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences that connect into the participants' daily lives. In the study, the families were divided into two groups, beginning their classes 6 months apart. Body measurements were taken at baseline and every 4 months to 16 months.
Detailed description
The specific aim of this pilot study was to use the group office visit model to provide an obesity treatment intervention for children 8-11 years of age in gender-specific groups and their parents in a clinic setting. The targeted lifestyle components of the intervention are less TV viewing, less sweetened beverages, smaller food portions, less fast food/better choices away from home and more general physical activity. The psychosocial component was based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in relation to personal goals and knowledge of the basics of nutrition and physical activity.
Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and their parents for a 12 weekly sessions group office visit program. Participants were randomized into 2 groups; one group starting in March 2006 and the lagged intervention control group starting in September 2006. Physical measurements and data collection were at baseline, 4, 8, 12, 16 months from randomization.
We evaluated the acceptability and feasibility of the group office visit model and effect size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability included ability to recruit within clinics, attendance, completion, follow-up rates, focus groups data and interviews of those who drop out. Evaluation of effect size included the patterns of growth over 15 months from baseline in relation to expected growth patterns and intervention exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Choices | Experimental | Behavioral: ChoicesThe 3-month twelve-session intervention, "Choices", included topics on nutrition, physical activity, and resiliency. Parents, boys and girls met separately. The sessions were developed for delivery by a family physician, two family medicine residents, and a nutritionist, who received training in positive psychology and resilience skills. All children were measured on the same dates, but children were randomly assigned to two cohorts, beginning 6 months apart, to facilitate statistical analysis by having one group experience "normal growth" on study prior to intervention. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.
Key exclusion criteria (1 listed)
- Conditions that would preclude dietary change or physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChoicesAlso: Resiliency, Nutrition, Physical ActivityThe 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency. | Behavioural | Choices |
Primary outcome
body mass index age-and-gender specific Z-score
Time frame: 9 months post intervention baseline
body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units. It is used to control for growth effects in children.
1 secondary outcome
weight for age-and-gender specific Z-score
Time frame: 9 months post-intervention baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl K Ritenbaugh, PhD, MPH principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choices in people with Obesity and Overweight, run by University of Arizona 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 1 inclusion and 1 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 29 Aug 2012. 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 age-and-gender specific Z-score (time frame: 9 months post intervention baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2012.