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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098902
• Other study ID #: 14-0547
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: May 28, 2015
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Obesity in young children remains a significant public health issue. Interventions targeting this age group are needed, but few have been successful. The most effective childhood obesity prevention interventions for young children thus far have involved significant parent engagement, suggesting that family-based interventions that take into account the needs of both parents and children are needed. But, 2 out of 3 adults are either overweight or obese, and the risk of obesity increases with at least one child under the age of 5 in the home. So not only is obesity among adults high, but maternal obesity is one of the strongest predictors of child obesity, meaning that intervening with overweight and obese mothers could be an effective way of preventing the development of obesity in their young children.

Many family-based or parent-targeted interventions conducted thus far have broadly targeted dietary intake and physical activity, but only a handful have had success in changing child behavior. Interestingly, when evaluating the dietary determinants of childhood obesity, sugar-sweetened beverage (SSB) consumption is most consistently associated with obesity across studies, more so than overall caloric intake, fruit and vegetable consumption, and intake of added dietary fats. Consumption of SSBs makes up 5-18% of preschoolers' recommended daily energy intake, with an average of 176 calories a day consumed from drinks such as caloric carbonated beverages, fruit drinks, sport drinks, and 100% fruit juice. Few interventions have targeted a reduction in SSBs and fruit juice in children, but results from a study in children ages 4-12 found that replacing SSBs with noncaloric beverages can lead to a lower increase in BMI z-scores over time. Reducing SSB consumption in adults is equally as important as in children, because adults consume 21% of their calories from SSBs alone, and consumption of SSBs is associated with a higher risk of obesity, non-alcoholic fatty liver disease, diabetes, the metabolic syndrome, and cardiovascular disease. Several adult intervention studies have shown that replacing caloric beverages, including SSBs, with water or noncaloric beverages can lead to weight loss in the absence of other prescribed changes.

While the research indicates that reducing SSB consumption in children and adults can lead to changes in weight, what is not yet known is if a mother-targeted behavioral intervention can successfully reduce intake of SSBs and fruit juice in preschool-aged children. Because mothers face many barriers to weight control behavior change, including time demands and lack of childcare, there is a need for interventions that are uniquely targeted to the needs of mothers and children, such that they minimize mothers' need to travel, prevent them from having to rearrange their schedules, and minimize the amount of time spent in participation in order to be successful at weight loss and changing their own and their child's behaviors.

This intervention has been developed to focus on changing a small set of behaviors, primarily SSB consumption, in mothers and their children ages 3-5. Guided by Social Cognitive Theory, the intervention will target increases in self-efficacy, outcome expectations, limit setting, and self-monitoring, and decreases in perceived barriers to behavior change. In addition, mothers will be asked to make other small changes in her own behavior to promote modest weight losses. The evidence from traditional behavioral weight loss intervention research has been adapted to focus on making small diet and physical activity changes more suitable for mothers of young children and to be delivered primarily via a mobile-based website and text messaging to reduce time demands and increase adherence. Mother-child dyads (N=42) will be randomized to either the Smart Moms intervention group (n=21) or to a waitlist control group (n=21) that will receive a modified version of the intervention after the 6-month assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Smart Moms Intervention
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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in child BMI z-score from baseline to 6 months	Change in child BMI z-score from baseline to 6 months will also be evaluated in this study. Children will be weighed wearing shorts and without shoes using a calibrated digital Tanita scale. Children's height will be measured at each time point using a wall-mounted stadiometer. Trained study staff will conduct these measurements following a standardized protocol. BMI z-score will be calculated using a program developed by the Centers for Disease Control (CDC).	Baseline, 6 months	No
Primary	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	No
Secondary	Change in maternal caloric beverage consumption from baseline to 3 months	A secondary outcome is the mother's average ounces per day of caloric beverage consumption change from baseline to 3 months. Caloric beverage consumption includes sugar-sweetened beverages, fruit juices, and alcoholic drinks. 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 dietary recall with the mother. Dietary data will be entered into NDSR, which will produce a report that includes intake of caloric beverages in ounces per day.	Baseline, 3 months	No
Secondary	Change in maternal weight from baseline to 6 months	Mothers will be weighed wearing shorts and without shoes using a calibrated digital Tanita scale. Trained study staff will conduct these measurements following a standardized protocol. Two measures will be completed and the average of the two will be used. Percent weight loss from baseline to 6 months will be calculated and used as the secondary outcome measure.	Baseline, 6 months	No