NCT01606891

Brief Summary

The goal of the Minnesota center is to integrate primary care, home, and community-based intervention strategies to promote sustained patterns of change in food intake, physical activity, and body weight among low income, ethnically diverse children. A culturally matched family connector will create linkages among the settings to support parents in making home environment and parenting behavior changes conducive to healthy growth and development in their children. Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted randomized controlled intervention on the primary outcome, child BMI, compared to a standard primary care-only intervention among 500 low income ethnic minority two to four year old children who are at or above the 50th percentile of BMI for age and gender. Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower BMI at 24 and 36 months, compared with children in the standard primary care only control group. Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted intervention on secondary outcomes, including change in child energy intake and physical activity energy expenditure, compared to a standard primary care-only intervention. Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower energy intake and higher energy expenditure over the three-year period, compared with children in the standard primary care-only control group. Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on hypothesized mediators of change in dietary intake, physical activity, and BMI. Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and physical activity environment will mediate changes in child energy intake and expenditure, and body mass index (BMI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2017

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

4.8 years

First QC Date

May 23, 2012

Last Update Submit

October 10, 2018

Conditions

Keywords

preschooler obesity preventioncommunity home visiting parentspreschooler excess BMI gainmulti-setting/component intervention

Outcome Measures

Primary Outcomes (1)

  • body mass index

    three years

Secondary Outcomes (1)

  • energy intake

    three years

Study Arms (2)

parent-targeted intervention

EXPERIMENTAL

experimental

Behavioral: multi-component/setting parent-targeted intervention

Primary Care

NO INTERVENTION

Standard primary care

Interventions

parents assigned to this group will be asked to participate in a program of home visiting, community parenting classes, and community food and physical activity resource links

parent-targeted intervention

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • A child and his or her parent(s) will be eligible for the study if:
  • the two to four year old child is scheduled to receive or eligible for (based on an upcoming birthday) a recommended well child visit conducted by a pediatric or family practice care provider;
  • the child has no medical problems that would preclude study participation as determined by the physician conducting the well child visit (e.g. serious disease that would make following guidelines for parent encouragement of healthy diet and physical activity infeasible);
  • the child's BMI is greater than or equal to the 50th percentile according to CDC age and sex reference standards http://www.cdc.gov/nchs/data/nhanes/growthcharts/bmiage.txt;
  • the child's parent/guardian agrees to participation in the study and is not planning to move out of the state in the next three years
  • the primary caregiver is willing and able to complete the evaluation measures and participate in intervention activities if assigned to the active intervention group.
  • the parent speaks either English or Spanish.

You may not qualify if:

  • A child will be excluded if she or he does not meet the above eligibility criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Division of Epidemiology & Community Health

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (7)

  • Jang S, Goodman L, Sherwood NE, French SA, Kunin-Batson A, de Brito JN. Early-Life Sociodemographic Factors and Cardiovascular Health in Preadolescence Among Low-Income and Racially and Ethnically Diverse Children. J Am Heart Assoc. 2025 Nov 4;14(21):e040692. doi: 10.1161/JAHA.124.040692. Epub 2025 Oct 23.

  • JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.

  • Berge JM, Miller J, Veblen-Mortenson S, Kunin-Batson A, Sherwood NE, French SA. A Bidirectional Analysis of Feeding Practices and Eating Behaviors in Parent/Child Dyads from Low-Income and Minority Households. J Pediatr. 2020 Jun;221:93-98.e20. doi: 10.1016/j.jpeds.2020.02.001. Epub 2020 Apr 1.

  • Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.

  • French SA, Sherwood NE, Veblen-Mortenson S, Crain AL, JaKa MM, Mitchell NR, Hotop AM, Berge JM, Kunin Batson AS, Truesdale K, Stevens J, Pratt C, Esposito L. Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012-2017. Am J Public Health. 2018 Dec;108(12):1695-1706. doi: 10.2105/AJPH.2018.304696.

  • Ruiz RM, Sommer EC, Tracy D, Banda JA, Economos CD, JaKa MM, Evenson KR, Buchowski MS, Barkin SL. Novel patterns of physical activity in a large sample of preschool-aged children. BMC Public Health. 2018 Feb 13;18(1):242. doi: 10.1186/s12889-018-5135-0.

  • Sherwood NE, French SA, Veblen-Mortenson S, Crain AL, Berge J, Kunin-Batson A, Mitchell N, Senso M. NET-Works: Linking families, communities and primary care to prevent obesity in preschool-age children. Contemp Clin Trials. 2013 Nov;36(2):544-54. doi: 10.1016/j.cct.2013.09.015. Epub 2013 Oct 9.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simone A French, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
  • Nancy E Sherwood, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 28, 2012

Study Start

June 1, 2012

Primary Completion

March 21, 2017

Study Completion

March 21, 2017

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations