OverweightNCT02098902
Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
A study testing Smart Moms Intervention in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Smart Moms Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Randomized Controlled Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Smart Moms Intervention
- Keywords
- Overweight, Obesity, Overnutrition, Weight Loss, Body Weight, Nutrition Disorders
- Medical subject headings
- Overweight, Obesity, Overnutrition, Weight Loss, Body Weight, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Moms InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smart Moms Intervention | Experimental | This arm will receive the Smart Moms intervention immediately following randomization. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Secondary outcomes (2)
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brooke T Nezami, MA, Principal investigator, University of North Carolina, Chapel HillDeborah F Tate, PhD, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098902
- Sponsor's protocol ID
- 14-0547
- Status last verified
- May 2015
- First submitted
- 25 Mar 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27542357
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
- ClinicalTrials.gov ID
- NCT02098902
- Acronym / sponsor ID
- 14-0547
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Overnutrition, Weight Loss, Body Weight, Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Moms Intervention | Experimental | Behavioral: Smart Moms InterventionThis arm will receive the Smart Moms intervention immediately following randomization. |
| Waitlist control group | No intervention | –This arm will receive a modified version of the Smart Moms intervention after the 6-month assessment. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Moms InterventionReduction 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. | Behavioural | Smart Moms Intervention |
Primary outcome
Change in child sugar-sweetened beverage consumption from baseline to 6 months
Time frame: Baseline, 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.
2 secondary outcomes
Change in maternal caloric beverage consumption from baseline to 3 months
Time frame: Baseline, 3 months
Change in maternal weight from baseline to 6 months
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Derived from this study: PubMed 27542357Nezami 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke T Nezami, MA principal investigator
University of North Carolina, Chapel Hill
Deborah F Tate, PhD study director
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Moms Intervention in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child sugar-sweetened beverage consumption from baseline to 6 months (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.