Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools

NCT02487251 | Completed Results

• 1 other identifier: 2015-68001-23239
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 4

Brief Summary

Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.

Conditions

Obesity

Keywords

Obesity; Family Mealtimes; Prevention

Outcome Measures

Primary Outcomes (1)

• Change in BMIz

  Research staff measured children without shoes or heavy clothing. Measures were taken twice and averaged. BMI was calculated and child BMIz derived. Child obesity was defined as BMI \> 95th percentile and overweight/obesity defined as a BMI \> 85th percentile for age and sex. Note that due to the COVID-19 pandemic, data on BMIz were not collected beginning in March 2020. The z-score is based on United States Centers for Disease Control growth references for children. A z-score of 0 reflects the 50th percentile based on the US CDC children's reference growth charts. A z-score \< -1.645 indicates that the child is underweight. A healthy BMIz score is between -1.645 and 1.036. BMIz \>1.036 = criteria for overweight; BMIz \>1.645 = criteria for obese

  Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

Secondary Outcomes (5)

• Change in Dietary Quality-Observed Fruit

  Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

• Change in Dietary Quality- Observed Vegetables

  Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

• Change in Dietary Quality-Parent Reported Fruit Intake

  Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

• Change in Dietary Quality-Parent Reported Vegetables

  Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

• Change in Frequency of Healthy Family Mealtimes

  Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

Study Arms (4)

Experimental: Phase 1 Usual Exposure

EXPERIMENTAL

Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.

Behavioral: Usual Exposure

Experimental: Phase 1 Mealtime support activities

EXPERIMENTAL

Participants will engage in mealtime support activities such as healthy eating classes, cooking demonstrations, provision of cookware, receipt of mealtime ingredients, receipt of prepared meals, make and eat meals).

Behavioral: Mealtime Supports

Experimental: Phase 2- Usual Exposure

EXPERIMENTAL

Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.

Behavioral: Usual Exposure

Experimental: Phase 2- Meal Delivery and Receipt of Cookware

EXPERIMENTAL

Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware

Behavioral: Mealtime Supports

Interventions

Mealtime Supports BEHAVIORAL

Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period.

Experimental: Phase 1 Mealtime support activities; Experimental: Phase 2- Meal Delivery and Receipt of Cookware

Usual Exposure BEHAVIORAL

Participants receive no supplemental information on family mealtimes beyond what is already currently received

Experimental: Phase 1 Usual Exposure; Experimental: Phase 2- Usual Exposure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preschool aged child

You may not qualify if:

• Significant feeding/eating disorders that would preclude participation in the interventions
• Child is a foster child
• Parent is non-English speaking

Sponsors & Collaborators

• Michigan State University: lead
• University of Michigan: collaborator

Study Sites (4)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Jackson Community Action Agency Head Start

Jackson, Michigan, 49201, United States

Location

Capital Are Community Services Head Start

Lansing, Michigan, 48912, United States

Location

Related Publications (2)

• Kerver JM, Brophy-Herb HE, Sturza J, Horodynski MA, Contreras DA, Stein M, Garner E, Hebert S, Williams JM, Kaciroti N, Martoccio T, Van Egeren LA, Choi H, Martin CK, Mitchell K, Dalimonte-Merckling D, Jeanpierre LA, Robinson CA, Lumeng JC. Supporting family meal frequency: Screening Phase results from the Simply Dinner Study. Appetite. 2022 Jul 1;174:106009. doi: 10.1016/j.appet.2022.106009. Epub 2022 Mar 22.

  PMID: 35337884 DERIVED

• Brophy-Herb HE, Horodynski M, Contreras D, Kerver J, Kaciroti N, Stein M, Lee HJ, Motz B, Hebert S, Prine E, Gardiner C, Van Egeren LA, Lumeng JC. Effectiveness of differing levels of support for family meals on obesity prevention among head start preschoolers: the simply dinner study. BMC Public Health. 2017 Feb 10;17(1):184. doi: 10.1186/s12889-017-4074-5.

  PMID: 28187722 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Holly E. Brophy-Herb, PI
• Organization: Michigan State University

hbrophy@msu.edu

517-355-3397

Study Officials

• Holly E. Brophy-Herb, Ph.D.

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: July 1, 2015
• Study Start: September 2, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-11

Locations

US (4)