Obesity, ChildhoodNCT03143660
FITLINE: Pediatric Practice-based Obesity Intervention to Support Families
A study testing Coaching and Materials in people with Obesity, Childhood, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Coaching and Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2017to 28 Jan 2022
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child BMI >= 85th percentile for age/sex,
- participating parent and child English speaking,
- parent has access to a telephone and is available to participate in telephone counseling sessions, and
- referred by the child's primary care provider.
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,
- genetic or endocrine causes of obesity,
- prescribed medications associated with weight gain,
- child on psychiatric medications, and/or
- morbidly obese (> 300 pounds). -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655
About this study
Official title: Pediatric Practice-based Obesity Intervention to Support Families:FITLINE
The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.
Read the detailed description
The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of > 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.
- Conditions
- Obesity, Childhood
- Being tested
- Coaching, Materials
- Keywords
- obesity
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingBehavioural
The eight weekly 30-minute Fitline calls provide personalized behavioral counseling and coaching to guide parents in improving their child's weight-related behaviors through targeted lifestyle changes recommended by the AAP for Stage 1, Prevention Plus. Calls are scheduled at a time convenient for the parent, including nights and weekends, with one nutritionist assigned to a family for consistency.
MaterialsBehavioural
The workbook contains tips and practical strategies for implementing the AAP-recommended behavior changes discussed in the counseling sessions to support families in making lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| Coaching | Active comparator | A parent support component consisting of eight weekly telephone counseling calls by centrally located nutritionists to provide parents coaching tailored to their family's unique needs to help them set goals and make targeted lifestyle changes recommended by the American Academy of Pediatrics (AAP) for Stage 1, Prevention Plus, accompanied by a parent booklet Receives: Behavioral: Coaching |
| Materials | Active comparator | Parents will receive the same educational materials provided in the Fitline family workbook mailed over 8 weeks to control for weekly contact and educational curriculum, but no Fitline counseling. Receives: Behavioral: Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing BMI in overweight and obese children.
BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 12-month follow-up
Measured: Baseline and 12-months post-baseline
Reducing BMI in overweight and obese children.
BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 6-month follow-up
Measured: Baseline and 6-months post-baseline
Secondary outcomes (8)
Improving the child's diet
It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in diet at 6-month follow-up. This will be measured by 24 hour dietary recalls conducted 3 times at each time point.
Measured: Baseline and 6-months post-baseline
Improving the child's diet
It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in diet at 12-month follow-up. This will be measured by 24 hour dietary diet recalls conducted three times at each time point.
Measured: Baseline and 12-months post-baseline
Improving the child's physical activity
It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in their level of physical activity at 6-month follow-up. This will be measured by the Physical Activity Questionnaire (PAQ-C).
Measured: Baseline and 6-months post-baseline
Improving the child's physical activity
It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in their level of physical activity at 12-month follow-up. This will be measured by the Physical Activity Questionnaire (PAQ-C).
Measured: Baseline and 12-months post-baseline
Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs
It is hypothesized that the effect of the Fitline-Coaching on child BMI will be predicted by changes in Social Cognitive Theory constructs. Parents will complete a survey assessing: (1) anticipated benefits of the behavior change (outcome expectations) (23-item questionnaire); (2) perceived support and barriers to addressing their child's behavior changes (15-item questionnaire); (3) self efficacy in helping their child improve their diet and physical activity (12-item) questionnaire; (4) behavioral capability (12-item questionnaire); and (5) knowledge (7-item questionnaire).
Children will complete a survey assessing (1) anticipated benefits of the behavior change (outcome expectations) (23-item questionnaire); (2) perceived support and barriers (67-item questionnaire); (3) self efficacy (16-item questionnaire); (4) behavioral capability (12-item questionnaire); and (5) knowledge (7 item questionnaire).
Measured: Baseline and 6-months post-baseline
Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs
The effect of the Fitline-Coaching on child BMI will be predicted by changes in Social Cognitive Theory constructs. Parents will complete a survey assessing: (1) the anticipated benefits of the behavior change (outcome expectations) using a 23-item questionnaire; (2) parent's perceived support and barriers to addressing their child's behavior changes using a 15 item questionnaire; (3) parent's self efficacy in helping their child improve their diet and physical activity using a 12 item questionnaire; (4) behavioral capability using a 12 item questionnaire; and (5) knowledge utilizing a 7 item questionnaire.
Children will complete a survey assessing (1) the anticipated benefits of the behavior change (outcome expectations) using a 23-item questionnaire; (2) their perceived support and barriers a 67-item questionnaire; (3) child's self efficacy using a 16-item questionnaire; (4) behavioral capability using a 12-item questionnaire; and (5) knowledge utilizing a 7-item questionnaire.
Measured: Baseline and 12-months post-baseline
Cost Effectiveness
Costs and health outcomes will be compared across conditions. Costs will include those of: (1) provider training and intervention, (2) office set-up and support, (3) intervention materials, and (4) Fitline coaching. The outcome will be change in BMI z-score.
Measured: Baseline and 12-months post-baseline
Cost Effectiveness
Costs and health outcomes will be compared across conditions. Costs will include those of: (1) provider training and intervention, (2) office set-up and support, (3) intervention materials, and (4) Fitline coaching. The outcome will be change in quality of life as measured by the quality adjusted Pediatric Quality of Life Inventory (PedsQL 4.0) scores.
Measured: Baseline and 12-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 posted8 May 2017
- Study start11 Oct 2017
- Primary completion1 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Pbert, University of Massachusetts, Worcester
- Investigators
- Lori Pbert, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143660
- Sponsor's protocol ID
- R01HL130505
- Status last verified
- Jan 2022
- First submitted
- 16 Apr 2017
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pbert L, Trivedi M, Druker S, Bram J, Olendzki B, Crawford S, Frisard C, Andersen V, Waring ME, Clements K, Schneider K, Geller AC. Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial. Contemp Clin Trials. 2021 May;104:106348. doi: 10.1016/j.cct.2021.106348. Epub 2021 Mar 8.
PubMed 33706002
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. 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
- NCT03143660
- Acronym / sponsor ID
- R01HL130505
- Conditions
- Obesity, Childhood
- Keywords
- obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 8 May 2017 (actual)
- 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 goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.
Detailed description
The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of > 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching | Active comparator | Behavioral: CoachingA parent support component consisting of eight weekly telephone counseling calls by centrally located nutritionists to provide parents coaching tailored to their family's unique needs to help them set goals and make targeted lifestyle changes recommended by the American Academy of Pediatrics (AAP) for Stage 1, Prevention Plus, accompanied by a parent booklet |
| Materials | Active comparator | Behavioral: MaterialsParents will receive the same educational materials provided in the Fitline family workbook mailed over 8 weeks to control for weekly contact and educational curriculum, but no Fitline counseling. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child BMI >= 85th percentile for age/sex,
- participating parent and child English speaking,
- parent has access to a telephone and is available to participate in telephone counseling sessions, and
- referred by the child's primary care provider.
Key exclusion criteria (6 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,
- genetic or endocrine causes of obesity,
- prescribed medications associated with weight gain,
- child on psychiatric medications, and/or
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 |
|---|---|---|
| CoachingThe eight weekly 30-minute Fitline calls provide personalized behavioral counseling and coaching to guide parents in improving their child's weight-related behaviors through targeted lifestyle changes recommended by the AAP for Stage 1, Prevention Plus. Calls are scheduled at a time convenient for the parent, including nights and weekends, with one nutritionist assigned to a family for consistency. | Behavioural | Coaching |
| MaterialsThe workbook contains tips and practical strategies for implementing the AAP-recommended behavior changes discussed in the counseling sessions to support families in making lifestyle changes. | Behavioural | Materials |
Primary outcome
Reducing BMI in overweight and obese children.
Time frame: Baseline and 12-months post-baseline
BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 12-month follow-up
Reducing BMI in overweight and obese children.
Time frame: Baseline and 6-months post-baseline
BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 6-month follow-up
8 secondary outcomes
Improving the child's diet
Time frame: Baseline and 6-months post-baseline
Improving the child's diet
Time frame: Baseline and 12-months post-baseline
Improving the child's physical activity
Time frame: Baseline and 6-months post-baseline
Improving the child's physical activity
Time frame: Baseline and 12-months post-baseline
Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs
Time frame: Baseline and 6-months post-baseline
Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs
Time frame: Baseline and 12-months post-baseline
Cost Effectiveness
Time frame: Baseline and 12-months post-baseline
Cost Effectiveness
Time frame: Baseline and 12-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 31 Jan 2022.
- Derived from this study: PubMed 33706002Pbert L, Trivedi M, Druker S, Bram J, Olendzki B, Crawford S, Frisard C, Andersen V, Waring ME, Clements K, Schneider K, Geller AC. Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial. Contemp Clin Trials. 2021 May;104:106348. doi: 10.1016/j.cct.2021.106348. Epub 2021 Mar 8.
- Individual participant dataSharing planned: No
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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.
Lori Pbert, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and Materials in people with Obesity, Childhood, 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 6 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 31 Jan 2022. 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?
Reducing BMI in overweight and obese children. (time frame: Baseline and 12-months post-baseline). The study lists 2 primary outcomes in all. 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 NCT03143660, which also lists 1 linked publication.
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 31 Jan 2022.