Pediatric ObesityPhase 1NCT02085434
Pediatric Practice-based Obesity Intervention to Support Families: FITLINE
A Phase 1 study testing FITLINE practice-based referral program in people with Pediatric Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The American Academy of Pediatrics (AAP) recommends a staged approach for pediatric practices to manage the growing problem of pediatric overweight and obesity, starting with Stage 1, Prevention Plus, which encourages families to improve basic lifestyle choices related to eating and activity in order to improve BMI… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- FITLINE practice-based referral program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2013
- Phase
- Phase 1
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child ages 8-12
- child BMI > 85th percentile for age/sex
- access to a telephone and parent available to participate in telephone counseling sessions,
- referred by the child's primary care provider (i.e., family deemed by the provider as able to participate in the study and interventions). If more than one child in a family is eligible, the oldest child will be invited to participate.
Who cannot join
- planning to move out of the area during the period of study participation
- medical condition that precludes adherence to AAP dietary and physical activity recommendations
- prescribed medications associated with weight gain, or (4) morbidly obese (> 300 pounds).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
The American Academy of Pediatrics (AAP) recommends a staged approach for pediatric practices to manage the growing problem of pediatric overweight and obesity, starting with Stage 1, Prevention Plus, which encourages families to improve basic lifestyle choices related to eating and activity in order to improve BMI status. This study will test the effectiveness of an innovative FITLINE telephone counseling program for overweight and obese 8-12 year olds seen in pediatric practices where nutritionists coach parents in improving their child's diet and physical activity, to reduce BMI. If found to be effective, the FITLINE program will provide a model for widespread implementation of Stage 1, Prevention Plus of the AAP expert committee recommendations through pediatric practices nationwide.
Read the detailed description
The American Academy of Pediatrics (AAP) recommends a staged approach to the management of pediatric overweight and obesity, starting with Stage 1, Prevention Plus, which encourages families to improve lifestyle choices related to eating and activity in order to improve BMI status. Most pediatric practices, however, have difficulty implementing these guidelines due to limited time and access to weight loss experts to whom they can refer their patients and families, and burden to families in accessing in-person weight loss services. In response, The investigators team developed the FITLINE pediatric practice-based referral program that provides practices an easily accessible resource to help families make AAP-recommended Stage 1 lifestyle changes. The program includes two components. The first, a pediatric practice-based component, consists of systems to identify overweight and obese children ages 8-12, a brief pediatric provider-delivered intervention, referral to the FITLINE counseling program, and feedback from the FITLINE nutritionist. The second, a parent support component, consists of six weekly FITLINE counseling telephone calls delivered by centrally located nutritionists who provide tailored, personalized coaching, along with a parent booklet to guide parents in setting goals and working with their child to make Stage 1 lifestyle changes. Providers receive a summary from the nutritionist of the progress made by families so they may support maintenance of an improved lifestyle, or refer for additional intervention. A nonrandomized intervention study with contemporaneous control was used. Parents and their children ages 8-12 with BMI ≥85th percentile (N=40) were recruited from two pediatric practices. Practices implemented systems to identify overweight/obese children, prompt brief provider intervention, and refer parents to 6-weekly FITLINE telephone counseling sessions with a nutritionist who guided parents in setting goals and helping their child make American Academy of Pediatrics (AAP)-recommended lifestyle changes. Child BMI and parent survey of child diet and physical activity were completed at baseline and 3 months. Medical record data from 44 children matched for age and BMI was collected.
- Conditions
- Pediatric Obesity
- Being tested
- FITLINE practice-based referral program
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FITLINE practice-based referral programBehavioural
The FITLINE practice-based referral program provides pediatric practices an easily accessible resource to help families make AAP-recommended Stage 1 lifestyle changes. The program includes a pediatric practice-based component (systems to identify overweight and obese children ages 8-12, a brief pediatric provider-delivered intervention, referral to the FITLINE counseling program, and feedback from the FITLINE nutritionist) and a parent support component(eight weekly FITLINE counseling telephone calls delivered by centrally located nutritionists). Providers receive a summary from the nutritionist of the progress made by families so they may support maintenance of an improved lifestyle, or refer for additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| FITLINE practice-based referral program | Experimental | Not described Receives: Behavioral: FITLINE practice-based referral program |
| Contemporaneous control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
The child's weight and height were measure in the clinic using standard methodology. BMI was calculated from weight (kg)/height squared (in meters) and BMI-z score for age/sex determined using Centers for Disease Control growth charts.
Measured: Baseline and 3 months post-baseline
Secondary outcomes (2)
Diet
Parents completed a survey assessing: (1) parent's feeding style using an 11-item questionnaire to assess interactions of the parent with the child during the dinner meal; (2) parent's perceived support and barriers to addressing their child's behavior changes using the Caregiver Attitudes and Beliefs Survey, created by the authors; (3) a 12-item survey regarding number of days their child engaged in key dietary behaviors (e.g., eat breakfast in the morning, eat fast food or restaurant meal, eat dinner with the family, (4) number of days in past week their child ate 5 fruit or vegetables, and drank water, fruit juice, and punch/sweet tea/soda/sports drinks; and (5) type of milk the child drinks.
Measured: Baseline and 3-months post-baseline
Physical activity behaviors
Parents completed a survey assessing: (1) parent's perceived support and barriers to addressing their child's behavior changes using the Caregiver Attitudes and Beliefs Survey, created by the authors; (2) a 12-item survey regarding number of days their child engaged in key physical activity behaviors (e.g., use computer or play video games, watch television, play sports).
Measured: Baseline and 3 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Lori Pbert, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085434
- Sponsor's protocol ID
- H00000948
- Status last verified
- Nov 2014
- First submitted
- 20 Feb 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Practice-based Obesity Intervention to Support Families: FITLINE
- ClinicalTrials.gov ID
- NCT02085434
- Acronym / sponsor ID
- H00000948
- Conditions
- Pediatric Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 12 Mar 2014 (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.
The American Academy of Pediatrics (AAP) recommends a staged approach for pediatric practices to manage the growing problem of pediatric overweight and obesity, starting with Stage 1, Prevention Plus, which encourages families to improve basic lifestyle choices related to eating and activity in order to improve BMI status. This study will test the effectiveness of an innovative FITLINE telephone counseling program for overweight and obese 8-12 year olds seen in pediatric practices where nutritionists coach parents in improving their child's diet and physical activity, to reduce BMI. If found to be effective, the FITLINE program will provide a model for widespread implementation of Stage 1, Prevention Plus of the AAP expert committee recommendations through pediatric practices nationwide.
Detailed description
The American Academy of Pediatrics (AAP) recommends a staged approach to the management of pediatric overweight and obesity, starting with Stage 1, Prevention Plus, which encourages families to improve lifestyle choices related to eating and activity in order to improve BMI status. Most pediatric practices, however, have difficulty implementing these guidelines due to limited time and access to weight loss experts to whom they can refer their patients and families, and burden to families in accessing in-person weight loss services. In response, The investigators team developed the FITLINE pediatric practice-based referral program that provides practices an easily accessible resource to help families make AAP-recommended Stage 1 lifestyle changes. The program includes two components. The first, a pediatric practice-based component, consists of systems to identify overweight and obese children ages 8-12, a brief pediatric provider-delivered intervention, referral to the FITLINE counseling program, and feedback from the FITLINE nutritionist. The second, a parent support component, consists of six weekly FITLINE counseling telephone calls delivered by centrally located nutritionists who provide tailored, personalized coaching, along with a parent booklet to guide parents in setting goals and working with their child to make Stage 1 lifestyle changes. Providers receive a summary from the nutritionist of the progress made by families so they may support maintenance of an improved lifestyle, or refer for additional intervention. A nonrandomized intervention study with contemporaneous control was used. Parents and their children ages 8-12 with BMI ≥85th percentile (N=40) were recruited from two pediatric practices. Practices implemented systems to identify overweight/obese children, prompt brief provider intervention, and refer parents to 6-weekly FITLINE telephone counseling sessions with a nutritionist who guided parents in setting goals and helping their child make American Academy of Pediatrics (AAP)-recommended lifestyle changes. Child BMI and parent survey of child diet and physical activity were completed at baseline and 3 months. Medical record data from 44 children matched for age and BMI was collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FITLINE practice-based referral program | Experimental | Behavioral: FITLINE practice-based referral program |
| Contemporaneous control | No intervention | – |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child ages 8-12
- child BMI > 85th percentile for age/sex
- access to a telephone and parent available to participate in telephone counseling sessions,
- referred by the child's primary care provider (i.e., family deemed by the provider as able to participate in the study and interventions). If more than one child in a family is eligible, the oldest child will be invited to participate.
Key exclusion criteria (3 listed)
- planning to move out of the area during the period of study participation
- medical condition that precludes adherence to AAP dietary and physical activity recommendations
- prescribed medications associated with weight gain, or (4) morbidly obese (> 300 pounds).
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 |
|---|---|---|
| FITLINE practice-based referral programThe FITLINE practice-based referral program provides pediatric practices an easily accessible resource to help families make AAP-recommended Stage 1 lifestyle changes. The program includes a pediatric practice-based component (systems to identify overweight and obese children ages 8-12, a brief pediatric provider-delivered intervention, referral to the FITLINE counseling program, and feedback from the FITLINE nutritionist) and a parent support component(eight weekly FITLINE counseling telephone calls delivered by centrally located nutritionists). Providers receive a summary from the nutritionist of the progress made by families so they may support maintenance of an improved lifestyle, or refer for additional intervention. | Behavioural | FITLINE practice-based referral program |
Primary outcome
Body Mass Index (BMI)
Time frame: Baseline and 3 months post-baseline
The child's weight and height were measure in the clinic using standard methodology. BMI was calculated from weight (kg)/height squared (in meters) and BMI-z score for age/sex determined using Centers for Disease Control growth charts.
2 secondary outcomes
Diet
Time frame: Baseline and 3-months post-baseline
Physical activity behaviors
Time frame: Baseline and 3 months post-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 21 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FITLINE practice-based referral program in people with Pediatric Obesity, run by University of Massachusetts, Worcester 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 4 inclusion and 3 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 21 Nov 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (BMI) (time frame: Baseline and 3 months post-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 21 Nov 2014.