ObesityNCT01973153
The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
A study testing Brief Motivational Counseling (BMC), Brief Motivational Counseling Plus Phone Calls (BMC + Phone) and Brief Motivational Counseling Plus Home Visits (BMC + Home) in people with Obesity, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Read more about this study
- Who is it for?
- Ages 2 years to 50 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Brief Motivational Counseling (BMC), Brief Motivational Counseling Plus Phone Calls (BMC + Phone) and Brief Motivational Counseling Plus Home Visits (BMC + Home)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2013
- 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 2 years to 50 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is 2-4 years old
- Latino or Black descent by maternal report
- Receiving services through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
Who cannot join
- Mother is younger than 18 years old
- Dad does not live in the Greater Hartford area or if they have plans to move out of the area in the next 12 months
- Child or mother has special needs (dietary, physical, and/or emotional) that would make the intervention inappropriate (e.g. failure to thrive, type 1 diabetes, cystic fibrosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.
- Conditions
- Obesity
- Being tested
- Brief Motivational Counseling (BMC), Brief Motivational Counseling Plus Phone Calls (BMC + Phone), Brief Motivational Counseling Plus Home Visits (BMC + Home)
- Keywords
- Obesity prevention, Weight management, Motivational Interviewing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational Counseling (BMC)Behavioural
3-5 minute BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors. During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies.
Brief Motivational Counseling Plus Phone Calls (BMC + Phone)Behavioural
BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress.
Brief Motivational Counseling Plus Home Visits (BMC + Home)Behavioural
BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress.
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Counseling (BMC) | Active comparator | 3-5 minute BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors. During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Receives: Behavioral: Brief Motivational Counseling (BMC) |
| Brief Motivational Counseling Plus Phone Calls (BMC+Phone) | Active comparator | BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress. Receives: Behavioral: Brief Motivational Counseling (BMC); Behavioral: Brief Motivational Counseling Plus Phone Calls (BMC + Phone) |
| Brief Motivational Counseling Plus Home Visits (BMC+Home) | Active comparator | BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress. Receives: Behavioral: Brief Motivational Counseling (BMC); Behavioral: Brief Motivational Counseling Plus Home Visits (BMC + Home) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI Percentile
BMI Percentile calculated using the 2000 revised CDC/NCH growth charts for the United States
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
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 ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Community Health Network
- Responsible party
- Principal investigator, Christine M Trapp, MD, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973153
- Sponsor's protocol ID
- CHNCT-012
- Status last verified
- Jun 2023
- First submitted
- 25 Oct 2013
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Gorin AA, Wiley J, Ohannessian CM, Hernandez D, Grant A, Cloutier MM. Steps to Growing Up Healthy: a pediatric primary care based obesity prevention program for young children. BMC Public Health. 2014 Jan 23;14:72. doi: 10.1186/1471-2458-14-72.
PubMed 24456698
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
- ClinicalTrials.gov ID
- NCT01973153
- Acronym / sponsor ID
- CHNCT-012
- Conditions
- Obesity
- Keywords
- Obesity prevention, Weight management, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- Community Health Network
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Oct 2013 (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.
Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Counseling (BMC) | Active comparator | Behavioral: Brief Motivational Counseling (BMC)3-5 minute BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors. During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. |
| Brief Motivational Counseling Plus Phone Calls (BMC+Phone) | Active comparator | Behavioral: Brief Motivational Counseling (BMC), Behavioral: Brief Motivational Counseling Plus Phone Calls (BMC + Phone)BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress. |
| Brief Motivational Counseling Plus Home Visits (BMC+Home) | Active comparator | Behavioral: Brief Motivational Counseling (BMC), Behavioral: Brief Motivational Counseling Plus Home Visits (BMC + Home)BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress. |
Who may qualify
- Ages
- 2 years to 50 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child is 2-4 years old
- Latino or Black descent by maternal report
- Receiving services through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
Key exclusion criteria (3 listed)
- Mother is younger than 18 years old
- Dad does not live in the Greater Hartford area or if they have plans to move out of the area in the next 12 months
- Child or mother has special needs (dietary, physical, and/or emotional) that would make the intervention inappropriate (e.g. failure to thrive, type 1 diabetes, cystic fibrosis)
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 |
|---|---|---|
| Brief Motivational Counseling (BMC)3-5 minute BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors. During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. | Behavioural | Brief Motivational Counseling (BMC), Brief Motivational Counseling Plus Home Visits (BMC+Home), Brief Motivational Counseling Plus Phone Calls (BMC+Phone) |
| Brief Motivational Counseling Plus Phone Calls (BMC + Phone)BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress. | Behavioural | Brief Motivational Counseling Plus Phone Calls (BMC+Phone) |
| Brief Motivational Counseling Plus Home Visits (BMC + Home)BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress. | Behavioural | Brief Motivational Counseling Plus Home Visits (BMC+Home) |
Primary outcome
Change in BMI Percentile
Time frame: baseline and 12 months
BMI Percentile calculated using the 2000 revised CDC/NCH growth charts for the United States
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 10 Jul 2023.
- Derived from this study: PubMed 24456698Gorin AA, Wiley J, Ohannessian CM, Hernandez D, Grant A, Cloutier MM. Steps to Growing Up Healthy: a pediatric primary care based obesity prevention program for young children. BMC Public Health. 2014 Jan 23;14:72. doi: 10.1186/1471-2458-14-72.
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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 study testing Brief Motivational Counseling (BMC), Brief Motivational Counseling Plus Phone Calls (BMC + Phone) and Brief Motivational Counseling Plus Home Visits (BMC + Home) in people with Obesity, run by Connecticut Children's Medical Center 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 3 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 10 Jul 2023. 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?
Change in BMI Percentile (time frame: baseline and 12 months). 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 NCT01973153, 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 10 Jul 2023.