Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smart Moms Intervention
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Overweight, Obesity, Overnutrition, Weight Loss, Body Weight, Nutrition Disorders
Eligibility Criteria
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Smart Moms Intervention
Waitlist control group
Arm Description
This arm will receive the Smart Moms intervention immediately following randomization.
This arm will receive a modified version of the Smart Moms intervention after the 6-month assessment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02098902
First Posted
March 25, 2014
Last Updated
May 28, 2015
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT02098902
Brief Title
Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
Official Title
Randomized Controlled Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Overnutrition, Weight Loss, Body Weight, Nutrition Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smart Moms Intervention
Arm Type
Experimental
Arm Description
This arm will receive the Smart Moms intervention immediately following randomization.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
This arm will receive a modified version of the Smart Moms intervention after the 6-month assessment.
Intervention Type
Behavioral
Intervention Name(s)
Smart Moms Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in child sugar-sweetened beverage consumption from baseline to 6 months
Description
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.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in maternal caloric beverage consumption from baseline to 3 months
Description
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.
Time Frame
Baseline, 3 months
Title
Change in maternal weight from baseline to 6 months
Description
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.
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Change in child BMI z-score from baseline to 6 months
Description
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).
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooke T Nezami, MA
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah F Tate, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27542357
Citation
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.
Results Reference
derived
Learn more about this trial
Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
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