OverweightFiSHNCT02659319
Families and Schools for Health
A study testing Family Lifestyle (FL), Family Dynamics (FD) and Peer Group (PG) in people with Overweight and Pediatric Obesity, run by Amanda Harrist.
Trial summary
The purpose of the study is to test the effectiveness of a child obesity intervention with multiple components targeting nutrition and/or psycho-social factors in children, their parents, and their classmates. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Overweight, Pediatric Obesity
- What is being tested?
- Family Lifestyle (FL), Family Dynamics (FD) and Peer Group (PG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jun 2010
- 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
- Children with BMI% greater than or equal to 75% who were enrolled in first grade in participating schools.
Who cannot join
- Children with BMI% < 75%.
About this study
Official title: Intervening in Family and Peer Contexts to Decrease Child Overweight
The purpose of the study is to test the effectiveness of a child obesity intervention with multiple components targeting nutrition and/or psycho-social factors in children, their parents, and their classmates. The specific aims of the study are to (1) Determine the effectiveness of two family-level interventions for improving child outcomes (unhealthy eating, low activity, and overweight); (2) Determine the extent to which adding a family dynamics component enhances the effectiveness of a family lifestyle intervention and improves the child outcomes listed above; and (3) Determine the extent to which a peer-level intervention improves the effectiveness of two family-level interventions among overweight children.
Read the detailed description
The Families and Schools for Health (FiSH) Project evaluates a psychosocial intervention that targets the family and peer contexts of overweight children. 23 rural schools were identified for participation (schools within a 90-mile radius of the PI's campus were targeted) and each was assigned to one of five intervention conditions using stratified random sampling, with stratification based on proximity to each other (to avoid spill-over effects) and proportion of Native American Indian students. A community sample of 1186 1st grade children, their families, and their teachers were successfully recruited. Anthropometric assessments were conducted with the 1186 children. Those who were not at Control schools were invited to participate in the intervention. 541 children qualified for the intervention (i.e., had BMI% > 75%), including 459 at Intervention schools and 82 at Control schools. Intervention conditions were (1) a 12-week Family Food \& Lifestyle intervention (FL), aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating; (2) a 12-week Family Food \& Lifestyle and Family Dynamics intervention (FL+FD) that additionally targets dysfunctional family patterns such as high conflict, poor parent-child communication, and parental over-control or permissiveness; and (3) a Peer Group (PG) intervention conducted throughout one semester of the school year that includes a guidance-type curriculum sensitizing children to the importance of social inclusion of all children. Thus, 5 treatment groups were evaluated in the intervention year and followed through 4th grade: FL, FL+FD, FL+PG, FL+FD+PG, and Control. Child psychosocial variables such as emotional eating, self-esteem, loneliness, and social withdrawal will be analyzed as mediators between family/peer contexts and child overweight.
- Conditions
- Overweight, Pediatric Obesity
- Being tested
- Family Lifestyle (FL), Family Dynamics (FD), Peer Group (PG)
- Keywords
- Child overweight, Child obesity, Family dynamics, Peer relationships, Family intervention, School intervention, Parenting
- Medical subject headings
- Overweight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Lifestyle (FL)Behavioural
12-week Family Food \& Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools.
Family Dynamics (FD)Behavioural
The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving. Material is delivered in psychoeducational groups in the children's schools.
Peer Group (PG)Behavioural
Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children
| Study group | Role | What they receive |
|---|---|---|
| Family Lifestyle (FL; n = 117) | Experimental | This arm includes the Family Food \& Lifestyle intervention (FL). Parents and children meet for 12 weekly, 90-minute psychoeducational groups in children's schools. They meet separately for 45 minutes and then conjointly for 45 minutes. Receives: Behavioral: Family Lifestyle (FL) |
| FL + Family Dynamics (FL+FD; n = 88) | Experimental | This arm includes the Family Food \& Lifestyle + Family Dynamics interventions (FL+FD). Parents and children meet separately for the full 90-minute psychoeducation sessions. The first 45 minutes are devoted to the Family Food \& Lifestyle intervention and the second 45 minutes to the Family Dynamics intervention. Receives: Behavioral: Family Lifestyle (FL); Behavioral: Family Dynamics (FD) |
| FL + Peer Group (FL+PG; n = 124) | Experimental | This arm includes the Family Food \& Lifestyle intervention plus the 12-session, Peer Group intervention. Receives: Behavioral: Family Lifestyle (FL); Behavioral: Peer Group (PG) |
| FL + FD + Peer Group (FL+FD+PG; n = 130) | Experimental | This arm includes the Family Food \& Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention. Receives: Behavioral: Family Lifestyle (FL); Behavioral: Family Dynamics (FD); Behavioral: Peer Group (PG) |
| Control (n = 82) | No intervention | Non-intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Change from Baseline to End of 1st grade
Height and weight measured at Wave 2 (Spring 1st grade), vs. Baseline at Fall 1st grade
Measured: Wave 2, Spring Year 1
Body Mass Change from Baseline to End of 2nd grade
Height and weight measured at Wave 3 (Spring 2nd grade), vs. Baseline at Wave 1, Fall 1st grade
Measured: Wave 3, Spring Year 2
Body Mass Change from Baseline to End of 3rd grade
Height and weight measured at Wave 4 (Spring 3rd grade), vs. Baseline at Wave 1, Fall 1st grade
Measured: Wave 4, Spring Year 3
Body Mass Change from Baseline to End of 4th grade
Height and weight measured at Wave 5 (Spring 4th grade) vs. Baseline at Wave 1, Fall 1st grade
Measured: Wave 5, Spring Year 4
Secondary outcomes (14)
Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Parent expectations about, parent modeling of, and parent perception of child beliefs regarding eating - parent report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Family problem solving, communication, affective responsiveness, affective involvement, & general family functioning - parent report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Parenting style (permissive, authoritative, authoritarian) - parent report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Parent response to child negative emotions - parent report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child temperament - child and parent report
Measured: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child emotion management - Parent and child report
Measured: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child behavior problems - Parent and teacher report (externalizing, internalizing)
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
School climate
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Peer relations - child, peer, and teacher reports
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child emotional and external eating - child self report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Body esteem - child self report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child self esteem - child self report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child depressive symptoms - child self report
Measured: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startMay 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amanda Harrist
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amanda Harrist, Oklahoma State University
- Investigators
- Amanda W Harrist, PhD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659319
- Sponsor's protocol ID
- NIFA/USDA Agreement No. 05545
- Other IDs
- HR07-044, HR08-043
- Acronym
- FiSH
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Harrist AW, Swindle TM, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. The Social and Emotional Lives of Overweight, Obese, and Severely Obese Children. Child Dev. 2016 Sep;87(5):1564-80. doi: 10.1111/cdev.12548. Epub 2016 May 25.
PubMed 27223340Shriver LH, Hubbs-Tait L, Harrist AW, Topham G, Page M. Child gender and weight status moderate the relation of maternal feeding practices to body esteem in 1st grade children. Appetite. 2015 Jun;89:62-9. doi: 10.1016/j.appet.2015.01.017. Epub 2015 Jan 23.
PubMed 25624022Harrist AW, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. Emotion regulation is related to children's emotional and external eating. J Dev Behav Pediatr. 2013 Oct;34(8):557-65. doi: 10.1097/DBP.0b013e3182a5095f.
PubMed 24131878Shriver LH, Harrist AW, Page M, Hubbs-Tait L, Moulton M, Topham G. Differences in body esteem by weight status, gender, and physical activity among young elementary school-aged children. Body Image. 2013 Jan;10(1):78-84. doi: 10.1016/j.bodyim.2012.10.005. Epub 2012 Nov 24.
PubMed 23228485Harrist, A. W., Topham, G. L., Hubbs-Tait, L., Page, M. C., Kennedy, T. S., & Shriver, L. H. (2012). What developmental science can contribute to a multidisciplinary understanding of childhood obesity. Child Development Perspectives, 6, 445-465. doi:10.1111/cdep.12004
Shriver LH, Harrist AW, Hubbs-Tait L, Topham G, Page M, Barrett A. Weight status, physical activity, and fitness among third-grade rural children. J Sch Health. 2011 Sep;81(9):536-44. doi: 10.1111/j.1746-1561.2011.00624.x.
PubMed 21831066Topham GL, Hubbs-Tait L, Rutledge JM, Page MC, Kennedy TS, Shriver LH, Harrist AW. Parenting styles, parental response to child emotion, and family emotional responsiveness are related to child emotional eating. Appetite. 2011 Apr;56(2):261-4. doi: 10.1016/j.appet.2011.01.007. Epub 2011 Jan 11.
PubMed 21232566Topham GL, Page MC, Hubbs-Tait L, Rutledge JM, Kennedy TS, Shriver L, Harrist AW. Maternal depression and socio-economic status moderate the parenting style/child obesity association. Public Health Nutr. 2010 Aug;13(8):1237-44. doi: 10.1017/S1368980009992163. Epub 2009 Dec 8.
PubMed 19968899Hubbs-Tait L, Kennedy TS, Page MC, Topham GL, Harrist AW. Parental feeding practices predict authoritative, authoritarian, and permissive parenting styles. J Am Diet Assoc. 2008 Jul;108(7):1154-61; discussion 1161-2. doi: 10.1016/j.jada.2008.04.008.
PubMed 18589022
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening in Family and Peer Contexts to Decrease Child Overweight
- ClinicalTrials.gov ID
- NCT02659319
- Acronym / sponsor ID
- FiSH / NIFA/USDA Agreement No. 05545
- Conditions
- Overweight, Pediatric Obesity
- Keywords
- Child overweight, Child obesity, Family dynamics, Peer relationships, Family intervention, School intervention, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Amanda HarristUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Jan 2016 (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 purpose of the study is to test the effectiveness of a child obesity intervention with multiple components targeting nutrition and/or psycho-social factors in children, their parents, and their classmates. The specific aims of the study are to (1) Determine the effectiveness of two family-level interventions for improving child outcomes (unhealthy eating, low activity, and overweight); (2) Determine the extent to which adding a family dynamics component enhances the effectiveness of a family lifestyle intervention and improves the child outcomes listed above; and (3) Determine the extent to which a peer-level intervention improves the effectiveness of two family-level interventions among overweight children.
Detailed description
The Families and Schools for Health (FiSH) Project evaluates a psychosocial intervention that targets the family and peer contexts of overweight children. 23 rural schools were identified for participation (schools within a 90-mile radius of the PI's campus were targeted) and each was assigned to one of five intervention conditions using stratified random sampling, with stratification based on proximity to each other (to avoid spill-over effects) and proportion of Native American Indian students. A community sample of 1186 1st grade children, their families, and their teachers were successfully recruited. Anthropometric assessments were conducted with the 1186 children. Those who were not at Control schools were invited to participate in the intervention. 541 children qualified for the intervention (i.e., had BMI% > 75%), including 459 at Intervention schools and 82 at Control schools. Intervention conditions were (1) a 12-week Family Food \& Lifestyle intervention (FL), aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating; (2) a 12-week Family Food \& Lifestyle and Family Dynamics intervention (FL+FD) that additionally targets dysfunctional family patterns such as high conflict, poor parent-child communication, and parental over-control or permissiveness; and (3) a Peer Group (PG) intervention conducted throughout one semester of the school year that includes a guidance-type curriculum sensitizing children to the importance of social inclusion of all children. Thus, 5 treatment groups were evaluated in the intervention year and followed through 4th grade: FL, FL+FD, FL+PG, FL+FD+PG, and Control. Child psychosocial variables such as emotional eating, self-esteem, loneliness, and social withdrawal will be analyzed as mediators between family/peer contexts and child overweight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Family Lifestyle (FL; n = 117) | Experimental | Behavioral: Family Lifestyle (FL)This arm includes the Family Food \& Lifestyle intervention (FL). Parents and children meet for 12 weekly, 90-minute psychoeducational groups in children's schools. They meet separately for 45 minutes and then conjointly for 45 minutes. |
| FL + Family Dynamics (FL+FD; n = 88) | Experimental | Behavioral: Family Lifestyle (FL), Behavioral: Family Dynamics (FD)This arm includes the Family Food \& Lifestyle + Family Dynamics interventions (FL+FD). Parents and children meet separately for the full 90-minute psychoeducation sessions. The first 45 minutes are devoted to the Family Food \& Lifestyle intervention and the second 45 minutes to the Family Dynamics intervention. |
| FL + Peer Group (FL+PG; n = 124) | Experimental | Behavioral: Family Lifestyle (FL), Behavioral: Peer Group (PG)This arm includes the Family Food \& Lifestyle intervention plus the 12-session, Peer Group intervention. |
| FL + FD + Peer Group (FL+FD+PG; n = 130) | Experimental | Behavioral: Family Lifestyle (FL), Behavioral: Family Dynamics (FD), Behavioral: Peer Group (PG)This arm includes the Family Food \& Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention. |
| Control (n = 82) | No intervention | –Non-intervention control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children with BMI% greater than or equal to 75% who were enrolled in first grade in participating schools.
Key exclusion criteria (1 listed)
- Children with BMI% < 75%.
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 |
|---|---|---|
| Family Lifestyle (FL)12-week Family Food \& Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools. | Behavioural | FL + FD + Peer Group (FL+FD+PG; n = 130), FL + Family Dynamics (FL+FD; n = 88), FL + Peer Group (FL+PG; n = 124), Family Lifestyle (FL; n = 117) |
| Family Dynamics (FD)The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving. Material is delivered in psychoeducational groups in the children's schools. | Behavioural | FL + FD + Peer Group (FL+FD+PG; n = 130), FL + Family Dynamics (FL+FD; n = 88) |
| Peer Group (PG)Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children | Behavioural | FL + FD + Peer Group (FL+FD+PG; n = 130), FL + Peer Group (FL+PG; n = 124) |
Primary outcome
Body Mass Change from Baseline to End of 1st grade
Time frame: Wave 2, Spring Year 1
Height and weight measured at Wave 2 (Spring 1st grade), vs. Baseline at Fall 1st grade
Body Mass Change from Baseline to End of 2nd grade
Time frame: Wave 3, Spring Year 2
Height and weight measured at Wave 3 (Spring 2nd grade), vs. Baseline at Wave 1, Fall 1st grade
Body Mass Change from Baseline to End of 3rd grade
Time frame: Wave 4, Spring Year 3
Height and weight measured at Wave 4 (Spring 3rd grade), vs. Baseline at Wave 1, Fall 1st grade
Body Mass Change from Baseline to End of 4th grade
Time frame: Wave 5, Spring Year 4
Height and weight measured at Wave 5 (Spring 4th grade) vs. Baseline at Wave 1, Fall 1st grade
14 secondary outcomes
Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Parent expectations about, parent modeling of, and parent perception of child beliefs regarding eating - parent report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Family problem solving, communication, affective responsiveness, affective involvement, & general family functioning - parent report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Parenting style (permissive, authoritative, authoritarian) - parent report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Parent response to child negative emotions - parent report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child temperament - child and parent report
Time frame: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child emotion management - Parent and child report
Time frame: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child behavior problems - Parent and teacher report (externalizing, internalizing)
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
School climate
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Peer relations - child, peer, and teacher reports
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child emotional and external eating - child self report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Body esteem - child self report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child self esteem - child self report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
Child depressive symptoms - child self report
Time frame: Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
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 20 Jan 2016.
- Background: PubMed 27223340Harrist AW, Swindle TM, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. The Social and Emotional Lives of Overweight, Obese, and Severely Obese Children. Child Dev. 2016 Sep;87(5):1564-80. doi: 10.1111/cdev.12548. Epub 2016 May 25.
- Background: PubMed 25624022Shriver LH, Hubbs-Tait L, Harrist AW, Topham G, Page M. Child gender and weight status moderate the relation of maternal feeding practices to body esteem in 1st grade children. Appetite. 2015 Jun;89:62-9. doi: 10.1016/j.appet.2015.01.017. Epub 2015 Jan 23.
- Background: PubMed 24131878Harrist AW, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. Emotion regulation is related to children's emotional and external eating. J Dev Behav Pediatr. 2013 Oct;34(8):557-65. doi: 10.1097/DBP.0b013e3182a5095f.
- Background: PubMed 23228485Shriver LH, Harrist AW, Page M, Hubbs-Tait L, Moulton M, Topham G. Differences in body esteem by weight status, gender, and physical activity among young elementary school-aged children. Body Image. 2013 Jan;10(1):78-84. doi: 10.1016/j.bodyim.2012.10.005. Epub 2012 Nov 24.
- BackgroundHarrist, A. W., Topham, G. L., Hubbs-Tait, L., Page, M. C., Kennedy, T. S., & Shriver, L. H. (2012). What developmental science can contribute to a multidisciplinary understanding of childhood obesity. Child Development Perspectives, 6, 445-465. doi:10.1111/cdep.12004
- Background: PubMed 21831066Shriver LH, Harrist AW, Hubbs-Tait L, Topham G, Page M, Barrett A. Weight status, physical activity, and fitness among third-grade rural children. J Sch Health. 2011 Sep;81(9):536-44. doi: 10.1111/j.1746-1561.2011.00624.x.
- Background: PubMed 21232566Topham GL, Hubbs-Tait L, Rutledge JM, Page MC, Kennedy TS, Shriver LH, Harrist AW. Parenting styles, parental response to child emotion, and family emotional responsiveness are related to child emotional eating. Appetite. 2011 Apr;56(2):261-4. doi: 10.1016/j.appet.2011.01.007. Epub 2011 Jan 11.
- Background: PubMed 19968899Topham GL, Page MC, Hubbs-Tait L, Rutledge JM, Kennedy TS, Shriver L, Harrist AW. Maternal depression and socio-economic status moderate the parenting style/child obesity association. Public Health Nutr. 2010 Aug;13(8):1237-44. doi: 10.1017/S1368980009992163. Epub 2009 Dec 8.
- Background: PubMed 18589022Hubbs-Tait L, Kennedy TS, Page MC, Topham GL, Harrist AW. Parental feeding practices predict authoritative, authoritarian, and permissive parenting styles. J Am Diet Assoc. 2008 Jul;108(7):1154-61; discussion 1161-2. doi: 10.1016/j.jada.2008.04.008.
- 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.
Amanda W Harrist, PhD principal investigator
Oklahoma State University
Questions about this trial
What is this clinical trial studying?
A study testing Family Lifestyle (FL), Family Dynamics (FD) and Peer Group (PG) in people with Overweight and Pediatric Obesity, run by Amanda Harrist.
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 1 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Body Mass Change from Baseline to End of 1st grade (time frame: Wave 2, Spring Year 1). The study lists 4 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 NCT02659319, which also lists 9 linked publications.
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 20 Jan 2016.