ObesityNCT00998348
Study of Parenting Intervention to Prevent Child Obesity
A study testing Parenting Program in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families must have at least one child age 2-5 years. The scientific rationale for focusing on this young population is that this age range includes the period often referred to as the "adiposity rebound," which has been identified as one of the critical periods for obesity development. Additionally, children of this age are still subject to strong parent and family influences which may be amenable to intervention.
- At least one parent or caregiver in the household must be overweight (BMI ≥25); however, this does not have to be the participating parent. The scientific rationale for focusing on families with at least one overweight parent is that having an overweight parent increases the child's risk of becoming overweight.
- Parents must be willing to participate in measures and intervention activities, and give consent for child's and his/her own participation.
Who cannot join
- Parents who are unable to speak English or comprehend standard age-level materials will be excluded. Currently funds are not available to translate and provide the program in Spanish or other languages.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7426
About this study
Official title: Healthy Child Weight Through Improved Parent Practices and Environmental Change
This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.
Read the detailed description
The early years between ages 3-7 are critical in the development of obesity. The importance of the family in the development of children's eating and activity behaviors has been emphasized by experts, yet to date no obesity prevention interventions incorporating a strong family focus with emphasis on improved parenting practices have been developed. The work proposed here will address this gap by testing the efficacy of an 8-mo parenting intervention designed to change both social and physical aspects of the home environment, which in turn will reduced % body fat in children. Subjects will be 280 families (one parent and one child from each) with at least one preschool-age child (2-5 years old). Following baseline measures, pairs will be randomized into intervention or control. The intervention will teach more effective parenting skills (child management, communication, routines, etc.), then apply these skills to specific practices that encourage healthier behaviors. The intervention will include group sessions and tailored phone calls facilitated by a registered dietitian who has also received training in parent education. Group sessions will use multiple teaching strategies and include separate child activities. Tailored calls will use motivational interviewing techniques to help parents overcome barriers to behavior change. The intervention is guided by Darling and Steinberg's Integrative Model of parenting, which highlights the importance of parenting values, style and practices in child socialization, and Deci and Ryan's Self-Determination Theory, which suggests ways to foster autonomous motivation to adopt new behaviors. The resulting intervention will help parents learn skills to reduce their parenting-related stress and create home environments that support healthy-weight behaviors. The primary outcome, % body fat in children, will be assessed using anthropometry and a validated prediction equation (Dezenberg, 1999). Analyses will include baseline measurements of the outcome as a covariate. Secondary measures include child and parent diet and physical activity, parenting style and practices, and home environment. Maintenance effect will be assessed following a 6-mo no-intervention period. A comprehensive analysis is included to test for mediation effects. This intensive intervention will create the exposure necessary to make life-altering changes in weight-related behaviors. Plans build on extensive formative work conducted by our experienced researchers.
- Conditions
- Obesity
- Being tested
- Parenting Program
- Keywords
- parenting, diet, physical activity, family, home, child
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting ProgramBehavioural
Also called Parenting SOS
The parenting program is an 8-month intervention for parents with preschool-age children designed to teach strategies and skills that help parents better manage their day to day stresses of parenting while also promoting healthy lifestyle behaviors. Topics will include stress management, child management, family routines, emotion regulation, and coparenting. In later sessions parents will be encouraged to draw on these general parenting skills to promote healthier nutrition and physical practices at home. The intervention will be delivered through in-person group sessions (n=12) and tailored one-on-one telephone calls (n=11). A complementary child program will be delivered to children while parents are attending the group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Comparison Group | No intervention | The comparison group will receive children's picture books (1 per month for the duration of the 8-month program). |
| Parenting Program | Experimental | The parenting program is an 8-month obesity prevention intervention for parents with preschool-age children. Receives: Behavioral: Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds.
Measured: baseline, 8 months and 14 months
Secondary outcomes (20)
Child BMI and Child BMI z-score based on measured child height, weight, and parent-reported date of birth
Measured: baseline, 8 months and 14 months
Parent BMI based on measured height and weight
Measured: baseline, 8 months and 14 months
Parent and child dietary intake measured with 3 unannounced dietary recalls collected via telephone interview (will not include foods eaten by child while outside of parent's care)
Measured: baseline, 8 months and 14 months
Parent and child physical activities assessed via 7-days of accelerometer monitoring (using the AciGraph GT3X monitor programed with 60-s epochs for adults and 15-s epochs for children)
Measured: baseline, 8 months and 14 months
Parenting-related stress assessed with the Parental Stress Index - Short Form (Abidin, 1995)
Measured: baseline, 8 months and 14 months
Autonomous motivation to change behaviors (parenting practices, feeding practices, and physical activity practices) will be assessed using modified versions of the Treatment Self-Regulation Questionnaire (Williams GC, 1996)
Measured: baseline, 8 months and 14 months
Self-efficacy for general parenting will be assessed with the Parenting Sense of Competence Scale (Johnston C, 1989)
Measured: baseline, 8 months and 14 months
Self-efficacy for implementing healthy nutrition and physical activity practices will be assessed with an instrument recently developed by the PI.
Measured: baseline, 8 months and 14 months
Parents' perceived social support and connectedness with regard to positive parenting and healthy feeding and physical activity practices will be assessed using modified versions of the Social Provisions Scale (Cutrona, 1987)
Measured: baseline, 8 months and 14 months
The Alabama Parenting Questionnaire - Preschool Revision (Clerkin, 2007)will be used to assess general parenting practices, specifically the use of positive parenting, inconsistent parenting, and punitive parenting
Measured: baseline, 8 months and 14 months
Difficulties in Emotion Regulation (Gratz, 2004) will be used to assess parental skills at regulating their own emotions
Measured: baseline, 8 months and 14 months
Coping with Children's Negative Emotions (Fabes, 1990) will be used to assess parental skill at helping the child deal with and manage his/her negative emotions
Measured: baseline, 8 months and 14 months
Confusion, Hubbub, and Order Scale (Matheny, 1995) will be used to assess the degree of order versus confusion in the home environment
Measured: baseline, 8 months and 14 months
The Parenting Convergence Scale (Ahrons, 1981) will be used to assess parental skill with coparenting
Measured: baseline, 8 months and 14 months
The Caregiver Feeding Style Questionnaire (Hughes SO, 2005) will be used to assess the two dimensions of parenting: demandingness and responsiveness as they relate to feeding practices
Measured: baseline, 8 months and 14 months
The Parental Feeding Style Questionnaire (Wardle, 2002) will be used to assess parents' use of emotional feeding, instrumental feeding, encouraging to eat, and control over eating
Measured: baseline, 8 months and 14 months
Nine subscales from the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman, 2007) will be used to assess child control, encouraging balance/variety, involvement, modeling, monitoring, pressure to eat, restriction for health or weight control,
Measured: baseline, 8 months and 14 months
One sub-scale from the Preschooler Feeding Questionnaire (Baughcum, 2001) will be used to assess structure during feeding interactions
Measured: baseline, 8 months and 14 months
Two items slightly modified from the Child Feeding Questionnaire (Birch, 2001) will be used to determine parent perceptions of child weight and concern about child becoming overweight
Measured: baseline, 8 months and 14 months
A variety of newly developed items drawn from the literature will be used to assess parent practices around child physical activity
Measured: baseline, 8 months and 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionJun 2012
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.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Dianne S. Ward, University of North Carolina, Chapel Hill
- Investigators
- Dianne S Ward, EdD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998348
- Sponsor's protocol ID
- 08-0354
- Other IDs
- 1R01HL091093-01A1
- Status last verified
- Jun 2013
- First submitted
- 16 Oct 2009
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ward DS, Vaughn AE, Bangdiwala KI, Campbell M, Jones DJ, Panter AT, Stevens J. Integrating a family-focused approach into child obesity prevention: rationale and design for the My Parenting SOS study randomized control trial. BMC Public Health. 2011 Jun 5;11:431. doi: 10.1186/1471-2458-11-431.
PubMed 21639940
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Child Weight Through Improved Parent Practices and Environmental Change
- ClinicalTrials.gov ID
- NCT00998348
- Acronym / sponsor ID
- 08-0354
- Conditions
- Obesity
- Keywords
- parenting, diet, physical activity, family, home, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Oct 2009 (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.
This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.
Detailed description
The early years between ages 3-7 are critical in the development of obesity. The importance of the family in the development of children's eating and activity behaviors has been emphasized by experts, yet to date no obesity prevention interventions incorporating a strong family focus with emphasis on improved parenting practices have been developed. The work proposed here will address this gap by testing the efficacy of an 8-mo parenting intervention designed to change both social and physical aspects of the home environment, which in turn will reduced % body fat in children. Subjects will be 280 families (one parent and one child from each) with at least one preschool-age child (2-5 years old). Following baseline measures, pairs will be randomized into intervention or control. The intervention will teach more effective parenting skills (child management, communication, routines, etc.), then apply these skills to specific practices that encourage healthier behaviors. The intervention will include group sessions and tailored phone calls facilitated by a registered dietitian who has also received training in parent education. Group sessions will use multiple teaching strategies and include separate child activities. Tailored calls will use motivational interviewing techniques to help parents overcome barriers to behavior change. The intervention is guided by Darling and Steinberg's Integrative Model of parenting, which highlights the importance of parenting values, style and practices in child socialization, and Deci and Ryan's Self-Determination Theory, which suggests ways to foster autonomous motivation to adopt new behaviors. The resulting intervention will help parents learn skills to reduce their parenting-related stress and create home environments that support healthy-weight behaviors. The primary outcome, % body fat in children, will be assessed using anthropometry and a validated prediction equation (Dezenberg, 1999). Analyses will include baseline measurements of the outcome as a covariate. Secondary measures include child and parent diet and physical activity, parenting style and practices, and home environment. Maintenance effect will be assessed following a 6-mo no-intervention period. A comprehensive analysis is included to test for mediation effects. This intensive intervention will create the exposure necessary to make life-altering changes in weight-related behaviors. Plans build on extensive formative work conducted by our experienced researchers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Group | No intervention | –The comparison group will receive children's picture books (1 per month for the duration of the 8-month program). |
| Parenting Program | Experimental | Behavioral: Parenting ProgramThe parenting program is an 8-month obesity prevention intervention for parents with preschool-age children. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Families must have at least one child age 2-5 years. The scientific rationale for focusing on this young population is that this age range includes the period often referred to as the "adiposity rebound," which has been identified as one of the critical periods for obesity development. Additionally, children of this age are still subject to strong parent and family influences which may be amenable to intervention.
- At least one parent or caregiver in the household must be overweight (BMI ≥25); however, this does not have to be the participating parent. The scientific rationale for focusing on families with at least one overweight parent is that having an overweight parent increases the child's risk of becoming overweight.
- Parents must be willing to participate in measures and intervention activities, and give consent for child's and his/her own participation.
Key exclusion criteria (1 listed)
- Parents who are unable to speak English or comprehend standard age-level materials will be excluded. Currently funds are not available to translate and provide the program in Spanish or other languages.
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 |
|---|---|---|
| Parenting ProgramAlso: Parenting SOSThe parenting program is an 8-month intervention for parents with preschool-age children designed to teach strategies and skills that help parents better manage their day to day stresses of parenting while also promoting healthy lifestyle behaviors. Topics will include stress management, child management, family routines, emotion regulation, and coparenting. In later sessions parents will be encouraged to draw on these general parenting skills to promote healthier nutrition and physical practices at home. The intervention will be delivered through in-person group sessions (n=12) and tailored one-on-one telephone calls (n=11). A complementary child program will be delivered to children while parents are attending the group sessions. | Behavioural | Parenting Program |
Primary outcome
Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds.
Time frame: baseline, 8 months and 14 months
20 secondary outcomes
Child BMI and Child BMI z-score based on measured child height, weight, and parent-reported date of birth
Time frame: baseline, 8 months and 14 months
Parent BMI based on measured height and weight
Time frame: baseline, 8 months and 14 months
Parent and child dietary intake measured with 3 unannounced dietary recalls collected via telephone interview (will not include foods eaten by child while outside of parent's care)
Time frame: baseline, 8 months and 14 months
Parent and child physical activities assessed via 7-days of accelerometer monitoring (using the AciGraph GT3X monitor programed with 60-s epochs for adults and 15-s epochs for children)
Time frame: baseline, 8 months and 14 months
Parenting-related stress assessed with the Parental Stress Index - Short Form (Abidin, 1995)
Time frame: baseline, 8 months and 14 months
Autonomous motivation to change behaviors (parenting practices, feeding practices, and physical activity practices) will be assessed using modified versions of the Treatment Self-Regulation Questionnaire (Williams GC, 1996)
Time frame: baseline, 8 months and 14 months
Self-efficacy for general parenting will be assessed with the Parenting Sense of Competence Scale (Johnston C, 1989)
Time frame: baseline, 8 months and 14 months
Self-efficacy for implementing healthy nutrition and physical activity practices will be assessed with an instrument recently developed by the PI.
Time frame: baseline, 8 months and 14 months
Parents' perceived social support and connectedness with regard to positive parenting and healthy feeding and physical activity practices will be assessed using modified versions of the Social Provisions Scale (Cutrona, 1987)
Time frame: baseline, 8 months and 14 months
The Alabama Parenting Questionnaire - Preschool Revision (Clerkin, 2007)will be used to assess general parenting practices, specifically the use of positive parenting, inconsistent parenting, and punitive parenting
Time frame: baseline, 8 months and 14 months
Difficulties in Emotion Regulation (Gratz, 2004) will be used to assess parental skills at regulating their own emotions
Time frame: baseline, 8 months and 14 months
Coping with Children's Negative Emotions (Fabes, 1990) will be used to assess parental skill at helping the child deal with and manage his/her negative emotions
Time frame: baseline, 8 months and 14 months
Confusion, Hubbub, and Order Scale (Matheny, 1995) will be used to assess the degree of order versus confusion in the home environment
Time frame: baseline, 8 months and 14 months
The Parenting Convergence Scale (Ahrons, 1981) will be used to assess parental skill with coparenting
Time frame: baseline, 8 months and 14 months
The Caregiver Feeding Style Questionnaire (Hughes SO, 2005) will be used to assess the two dimensions of parenting: demandingness and responsiveness as they relate to feeding practices
Time frame: baseline, 8 months and 14 months
The Parental Feeding Style Questionnaire (Wardle, 2002) will be used to assess parents' use of emotional feeding, instrumental feeding, encouraging to eat, and control over eating
Time frame: baseline, 8 months and 14 months
Nine subscales from the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman, 2007) will be used to assess child control, encouraging balance/variety, involvement, modeling, monitoring, pressure to eat, restriction for health or weight control,
Time frame: baseline, 8 months and 14 months
One sub-scale from the Preschooler Feeding Questionnaire (Baughcum, 2001) will be used to assess structure during feeding interactions
Time frame: baseline, 8 months and 14 months
Two items slightly modified from the Child Feeding Questionnaire (Birch, 2001) will be used to determine parent perceptions of child weight and concern about child becoming overweight
Time frame: baseline, 8 months and 14 months
A variety of newly developed items drawn from the literature will be used to assess parent practices around child physical activity
Time frame: baseline, 8 months and 14 months
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 17 Jun 2013.
- Derived from this study: PubMed 21639940Ward DS, Vaughn AE, Bangdiwala KI, Campbell M, Jones DJ, Panter AT, Stevens J. Integrating a family-focused approach into child obesity prevention: rationale and design for the My Parenting SOS study randomized control trial. BMC Public Health. 2011 Jun 5;11:431. doi: 10.1186/1471-2458-11-431.
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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.
Dianne S Ward, EdD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Program in people with Obesity, run by University of North Carolina, Chapel Hill 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 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 17 Jun 2013. 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?
Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (time frame: baseline, 8 months and 14 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 NCT00998348, 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 17 Jun 2013.