Toddler Overweight Prevention Study Among Low-Income Families

NCT02615158 | Completed Results DMC

• 3 other identifiers: H-27980R01HD056099R03HD077156
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 2

Brief Summary

The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.

Conditions

Overweight; Obesity; Depression

Keywords

Feeding practices; Diet; Physical activity; Prevention

Outcome Measures

Primary Outcomes (2)

• Change of Body Mass Index (BMI) Z-score for Toddlers

  Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.

  Baseline to 12-month Follow-up

• Change in Body Mass Index (BMI) Score Among Mothers

  Change body mass index (BMI, kg/m\^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.

  Baseline to 12 month Follow-up

Secondary Outcomes (5)

• Change of Diet Quality for Toddlers

  Baseline to 12-month Follow-up

• Change of Diet Quality for Mothers

  Baseline to 12-month Follow-up

• Change of Child Physical Activity

  Baseline to 12-month Follow-up

• Change of Maternal Physical Activity

  Baseline-12 month follow up

• Feeding Style

  Baseline to 12 month Follow-up

Study Arms (3)

Maternal Physical Activity and Nutrition

EXPERIMENTAL

A maternal intervention focusing on healthy diet and physical activity patterns for mothers.

Behavioral: Maternal Physical Activity and Nutrition

Parenting

EXPERIMENTAL

A toddler parenting intervention focusing on parenting, limit setting, and development strategies.

Behavioral: Parenting

Child Safety

EXPERIMENTAL

Attention control group. The parents received intervention to promote safety among toddlers.

Behavioral: Child Safety

Interventions

Maternal Physical Activity and Nutrition BEHAVIORAL

At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.

Maternal Physical Activity and Nutrition

Parenting BEHAVIORAL

Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.

Parenting

Child Safety BEHAVIORAL

The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.

Child Safety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 yrs old
• Has child between 12-32 months
• Child able to walk
• Birth weight of child at least 5lbs. 8oz.

You may not qualify if:

• Mom cannot be pregnant
• No known congenital problems or disabilities

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Johns Hopkins University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Maryland, School of Medicine

Baltimore, Maryland, 21201, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (6)

• Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.

  PMID: 16595758 BACKGROUND

• Campbell KL, Wang Y, Kuhn AP, Black MM, Hager ER. An ecological momentary assessment study of physical activity behaviors among mothers of toddlers from low-income households. BMC Womens Health. 2021 Mar 22;21(1):120. doi: 10.1186/s12905-021-01243-2.

  PMID: 33752659 DERIVED

• Covington L, Armstrong B, Trude ACB, Black MM. Longitudinal Associations Among Diet Quality, Physical Activity and Sleep Onset Consistency With Body Mass Index z-Score Among Toddlers in Low-income Families. Ann Behav Med. 2021 Jun 28;55(7):653-664. doi: 10.1093/abm/kaaa100.

  PMID: 33196078 DERIVED

• Black MM, Hager ER, Wang Y, Hurley KM, Latta LW, Candelaria M, Caulfield LE. Toddler obesity prevention: A two-generation randomized attention-controlled trial. Matern Child Nutr. 2021 Jan;17(1):e13075. doi: 10.1111/mcn.13075. Epub 2020 Sep 4.

  PMID: 32885909 DERIVED

• Armstrong B, Covington LB, Hager ER, Black MM. Objective sleep and physical activity using 24-hour ankle-worn accelerometry among toddlers from low-income families. Sleep Health. 2019 Oct;5(5):459-465. doi: 10.1016/j.sleh.2019.04.005. Epub 2019 Jun 3.

  PMID: 31171491 DERIVED

• Wang Y, Gielen AC, Magder LS, Hager ER, Black MM. A randomised safety promotion intervention trial among low-income families with toddlers. Inj Prev. 2018 Feb;24(1):41-47. doi: 10.1136/injuryprev-2016-042178. Epub 2017 Apr 6.

  PMID: 28385953 DERIVED

Related Links

• Study Website

MeSH Terms

Conditions

Overweight; Obesity; Depression; Motor Activity

Interventions

Nutritional Status; Psychological Tests; Child Restraint Systems

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Behavioral Disciplines and Activities; Infant Equipment; Equipment and Supplies; Protective Devices; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Data analysis was delayed due to extended period of time for coding the mother-toddler interaction data, related to personnel and funding.

Results Point of Contact

• Title: Dr. Maureen Black
• Organization: University of Maryland School of Medicine

mblack@som.umaryland.edu

410-706-2136

Study Officials

• Maureen M Black, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: November 26, 2015
• Study Start: April 1, 2006
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-05

Locations

US (2)