ObesityPTTNCT02222766
Parents and Tots Together: A Family-Based Obesity Prevention Intervention
A study testing Parents and Tots Together Program in people with Obesity, run by University of Guelph at 1 site in United States.
Trial summary
The obesity epidemic has spared no age group, including our youngest children. My and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Parents and Tots Together Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parents who have a child aged 2-5 years
- respond to interviews and questionnaires in English or Spanish
Who cannot join
- any families who plan to move during the study period
- children or parents with severe health conditions that would prohibit them from participating in study activities
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Pilgrim Health Care
Boston, Massachusetts, 02215
About this study
Official title: Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children
The obesity epidemic has spared no age group, including our youngest children. My and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical activity. To capitalize on this enthusiasm, I will create and test an intervention that embeds strategies to improve child weight-related behaviors within a general skills parenting program.
The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children age 2 through 5 years. To achieve this goal, my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically diverse, primarily low-income families. Our specific aims are to:
- Determine the extent to which the intervention, compared with a control condition, results in a smaller age-associated increase in body mass index (BMI) among children after a 3- month intervention and a 9-month follow-up period (primary outcome).
- Determine the extent to which the intervention, compared with a control condition, results in:
- Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.
- Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.
- Improved child weight-related behaviors, i.e., increased sleep duration and physical activity, and reduced sugar-sweetened beverage intake and television/video viewing.
- Conditions
- Obesity
- Being tested
- Parents and Tots Together Program, Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents and Tots Together ProgramBehavioural
Group-based parenting program, 9 sessions offered weekly
ControlBehavioural
Minimal attention control- 9 weekly mailed information on general child development
| Study group | Role | What they receive |
|---|---|---|
| Parents and Tots Together Program | Experimental | 9-week group-based parenting program Receives: Behavioral: Parents and Tots Together Program |
| Control | Active comparator | Minimal attention control- weekly mailed information on general child development for 9 weeks Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI), adjusted for age and gender
Measured: baseline, post-intervention, 9-month follow-up
Secondary outcomes (3)
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Measured: baseline, post-intervention, 9-month follow-up
Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.
Measured: baseline, post-intervention, 9-month follow-up
Change in parental feeding behaviors, i.e., controlling feeding practices
Measured: baseline, post-intervention, 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJun 2011
- Primary completionOct 2013
- Study completionOct 2013
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Harvard Medical School (HMS and HSDM), Johns Hopkins University
- Responsible party
- Principal investigator, Jess Haines, University of Guelph
- Investigators
- Jess Haines, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222766
- Sponsor's protocol ID
- 190331-41
- Acronym
- PTT
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children
- ClinicalTrials.gov ID
- NCT02222766
- Acronym / sponsor ID
- PTT / 190331-41
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- American Heart Association, Harvard Medical School (HMS and HSDM), Johns Hopkins University
- Study start
- Jun 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Aug 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 obesity epidemic has spared no age group, including our youngest children. My and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical activity. To capitalize on this enthusiasm, I will create and test an intervention that embeds strategies to improve child weight-related behaviors within a general skills parenting program.
The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children age 2 through 5 years. To achieve this goal, my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically diverse, primarily low-income families. Our specific aims are to:
- Determine the extent to which the intervention, compared with a control condition, results in a smaller age-associated increase in body mass index (BMI) among children after a 3- month intervention and a 9-month follow-up period (primary outcome).
- Determine the extent to which the intervention, compared with a control condition, results in:
- Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.
- Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.
- Improved child weight-related behaviors, i.e., increased sleep duration and physical activity, and reduced sugar-sweetened beverage intake and television/video viewing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents and Tots Together Program | Experimental | Behavioral: Parents and Tots Together Program9-week group-based parenting program |
| Control | Active comparator | Behavioral: ControlMinimal attention control- weekly mailed information on general child development for 9 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- parents who have a child aged 2-5 years
- respond to interviews and questionnaires in English or Spanish
Key exclusion criteria (2 listed)
- any families who plan to move during the study period
- children or parents with severe health conditions that would prohibit them from participating in study activities
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 |
|---|---|---|
| Parents and Tots Together ProgramGroup-based parenting program, 9 sessions offered weekly | Behavioural | Parents and Tots Together Program |
| ControlMinimal attention control- 9 weekly mailed information on general child development | Behavioural | Control |
Primary outcome
Change in body mass index (BMI), adjusted for age and gender
Time frame: baseline, post-intervention, 9-month follow-up
3 secondary outcomes
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Time frame: baseline, post-intervention, 9-month follow-up
Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.
Time frame: baseline, post-intervention, 9-month follow-up
Change in parental feeding behaviors, i.e., controlling feeding practices
Time frame: baseline, post-intervention, 9-month follow-up
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 Aug 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.
Jess Haines, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents and Tots Together Program in people with Obesity, run by University of Guelph 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 2 inclusion and 2 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 Aug 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.
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 body mass index (BMI), adjusted for age and gender (time frame: baseline, post-intervention, 9-month follow-up). 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 Aug 2014.