Clinical trial NCT02193009: SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages
Official title: SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Physical Activity
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: University of Kansas
name: University of Hawaii
First posted: 2014-07-17
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore).

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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months
timeFrame: baseline, 6-months
Secondary outcomes:
measure: Change from Baseline in Minutes of Physical Activity at 6 months
timeFrame: baseline, 6-months
Other outcomes:
measure: Change from Baseline in Weight at 6 months
timeFrame: baseline, 6-months
measure: Change from Baseline in C13 biomarker at 6 months
timeFrame: baseline, 6-months
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Jamie M Zoellner, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.