Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5

NCT02098902 | Completed

• 1 other identifier: 14-0547
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effect of a novel six-month behavioral program to reduce sugar-sweetened beverage consumption among preschoolers and their mothers. The behavioral intervention tested will be delivered via a mobile-based website, text messages and email in addition to one face-to-face group meeting. The intervention will be compared to a waitlist control group. Participants will be 42 overweight/obese mothers and their children ages 3-5 living in the Chapel Hill/Raleigh/Durham area. Sugar-sweetened beverage consumption and weight in both children and mothers will be measured at three- and six-months post-randomization. It is hypothesized that children randomized to the intervention will have a greater reduction in sugar-sweetened beverage consumption at 6 months compared to children randomized to the control group.

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; Overnutrition; Weight Loss; Body Weight; Nutrition Disorders

Outcome Measures

Primary Outcomes (1)

• Change in child sugar-sweetened beverage consumption from baseline to 6 months

  The primary outcome is the child's average ounces per day of sugar-sweetened beverage consumption change from baseline to 6 months. Sugar-sweetened beverage consumption includes all beverages sweetened with sugar in addition to 100% fruit juice. It will be measured using a 24-hour dietary recall during the in-person assessment visit. A staff member trained to conduct dietary recalls will conduct a mother-reported dietary recall for the child. Dietary data will be entered into the Nutrition Data System for Research (NDSR), which will produce a report that includes intake of sugar-sweetened beverages in ounces per day.

  Baseline, 6 months

Secondary Outcomes (2)

• Change in maternal caloric beverage consumption from baseline to 3 months

  Baseline, 3 months

• Change in maternal weight from baseline to 6 months

  Baseline, 6 months

Other Outcomes (1)

• Change in child BMI z-score from baseline to 6 months

  Baseline, 6 months

Study Arms (2)

Smart Moms Intervention

EXPERIMENTAL

This arm will receive the Smart Moms intervention immediately following randomization.

Behavioral: Smart Moms Intervention

Waitlist control group

NO INTERVENTION

This arm will receive a modified version of the Smart Moms intervention after the 6-month assessment.

Interventions

Smart Moms Intervention BEHAVIORAL

Reduction in child sugar-sweetened beverage consumption and maternal caloric beverage consumption, in addition to self-selected 100-calorie dietary and physical activity changes made by the mother to promote modest weight loss. Content will be delivered via one in-person group meeting, weekly online lessons, and weekly text messages. Mothers will self-monitor their weight and their own and their child's beverage consumption via text message every 2-3 days.

Smart Moms Intervention

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The parent is female
• The mother has a BMI between 25 and 50
• The mother has a smartphone with data and text messaging plan
• The child is between the ages of 3-5
• The child consumes at least 12 ounces of sugar-sweetened beverages/100% fruit juice per day

You may not qualify if:

• The mother cannot speak or read English
• They cannot participate in assessment visits at the UNC Weight Research Program
• The mother is currently participating in another weight loss program
• The mother is pregnant or planning to become pregnant in next 6 months
• They are planning on moving out of the study area in the next 6 months
• The mother has a diagnosis of schizophrenia or bipolar disorder, or hospitalization for a psychiatric diagnosis in the past year
• The mother has excessive intake of alcoholic beverages defined as \>14 servings per week or they report a diagnosis of substance or alcohol abuse (on screening survey)
• The mother is unable to safely participate in alternatives to sedentary behavior including standing and walking

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Nezami BT, Lytle LA, Tate DF. A randomized trial to reduce sugar-sweetened beverage and juice intake in preschool-aged children: description of the Smart Moms intervention trial. BMC Public Health. 2016 Aug 19;16(1):837. doi: 10.1186/s12889-016-3533-8.

  PMID: 27542357 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Overnutrition; Weight Loss; Body Weight; Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Brooke T Nezami, MA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Deborah F Tate, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

US (1)