- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02193009
SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this application targeting at-risk residents from rural southwest Virginia counties is to:
1. Determine the effectiveness of SIPsmart and SIPsmartER at decreasing SSB consumption when compared to a matched contact control group targeting walking behaviors.
The secondary aims are to:
- Explore causal pathways through which changes in SSB attitudes, subjective norms, and perceived behavioral control influence behavioral intentions and SSB consumption, and the extent to which changes in SSB consumption are mediated by changes in nutrition numeracy and nutrition-related media literacy.
- Determine the reach and representativeness, adoption feasibility, degree to which the intervention was implemented as intended (and associated costs), and the maintenance of behavior changes 6 and 12 months post intervention (i.e., 18 months from baseline) when compared to control.
- Assess intervention impacts on body weight.
An exploratory aim is to:
1. Assess intervention impacts on a 13C biomarker, a new non-invasive biomarker fingerstick technique for added sugar intake, and evaluate the changes in this biomarker over time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
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Blacksburg, Virginia, United States, 24060
- Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria included English-speaking adults >18 years of age, who consume >200 SSB kcals/day, self-report no contraindications for physical activity, and have regular access to a telephone.
Exclusion Criteria:
- To minimize potential confounds, only one member per household is eligible to enroll and individuals cannot be concurrently enrolled in a Cooperative Extension program because these programs focus on improving nutrition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SIPsmartER, behavioral intervention
Aimed at decreasing sugar-sweetened beverage consumption
|
6-month behavioral trial
|
Active Comparator: Move More, behavioral intervention
Aimed at physical activity promotion
|
6 month behavioral trial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months
Time Frame: baseline, 6-months
|
baseline, 6-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Minutes of Physical Activity at 6 months
Time Frame: baseline, 6-months
|
baseline, 6-months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Weight at 6 months
Time Frame: baseline, 6-months
|
baseline, 6-months
|
Change from Baseline in C13 biomarker at 6 months
Time Frame: baseline, 6-months
|
baseline, 6-months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jamie M Zoellner, PhD, RD, Virginia Polytechnic Institute and State University
Publications and helpful links
General Publications
- Zoellner JM, You W, Estabrooks PA, Chen Y, Davy BM, Porter KJ, Hedrick VE, Bailey A, Kruzliakova N. Supporting maintenance of sugar-sweetened beverage reduction using automated versus live telephone support: findings from a randomized control trial. Int J Behav Nutr Phys Act. 2018 Oct 4;15(1):97. doi: 10.1186/s12966-018-0728-7.
- Kruzliakova N, Estabrooks PA, You W, Hedrick V, Porter K, Kiernan M, Zoellner J. The Relationship Between the Stanford Leisure-Time Activity Categorical Item and the Godin Leisure-Time Exercise Questionnaire Among Rural Intervention Participants of Varying Health Literacy Status. J Phys Act Health. 2018 Apr 1;15(4):269-278. doi: 10.1123/jpah.2017-0284. Epub 2018 Feb 9.
- Hedrick VE, Davy BM, You W, Porter KJ, Estabrooks PA, Zoellner JM. Dietary quality changes in response to a sugar-sweetened beverage-reduction intervention: results from the Talking Health randomized controlled clinical trial. Am J Clin Nutr. 2017 Apr;105(4):824-833. doi: 10.3945/ajcn.116.144543. Epub 2017 Mar 1.
- Estabrooks P, You W, Hedrick V, Reinholt M, Dohm E, Zoellner J. A pragmatic examination of active and passive recruitment methods to improve the reach of community lifestyle programs: The Talking Health Trial. Int J Behav Nutr Phys Act. 2017 Jan 19;14(1):7. doi: 10.1186/s12966-017-0462-6.
- Zoellner JM, Hedrick VE, You W, Chen Y, Davy BM, Porter KJ, Bailey A, Lane H, Alexander R, Estabrooks PA. Effects of a behavioral and health literacy intervention to reduce sugar-sweetened beverages: a randomized-controlled trial. Int J Behav Nutr Phys Act. 2016 Mar 22;13:38. doi: 10.1186/s12966-016-0362-1.
- Hedrick VE, Zoellner JM, Jahren AH, Woodford NA, Bostic JN, Davy BM. A Dual-Carbon-and-Nitrogen Stable Isotope Ratio Model Is Not Superior to a Single-Carbon Stable Isotope Ratio Model for Predicting Added Sugar Intake in Southwest Virginian Adults. J Nutr. 2015 Jun;145(6):1362-9. doi: 10.3945/jn.115.211011. Epub 2015 Apr 8.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01CA154364 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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