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SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages

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ClinicalTrials.gov Identifier: NCT02193009
Recruitment Status : Unknown
Verified June 2015 by Jamie Zoellner, Virginia Polytechnic Institute and State University.
Recruitment status was:  Active, not recruiting
First Posted : July 17, 2014
Last Update Posted : June 19, 2015
Sponsor:
Collaborators:
University of Kansas
University of Hawaii
Information provided by (Responsible Party):
Jamie Zoellner, Virginia Polytechnic Institute and State University

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).

Condition or disease Intervention/treatment Phase
Dietary Habits Physical Activity Behavioral: SipSmarter Behavioral: MoveMore Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages
Study Start Date : July 2011
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SIPsmartER, behavioral intervention
Aimed at decreasing sugar-sweetened beverage consumption
Behavioral: SipSmarter
6-month behavioral trial

Active Comparator: Move More, behavioral intervention
Aimed at physical activity promotion
Behavioral: MoveMore
6 month behavioral trial




Primary Outcome Measures :
  1. Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months [ Time Frame: baseline, 6-months ]

Secondary Outcome Measures :
  1. Change from Baseline in Minutes of Physical Activity at 6 months [ Time Frame: baseline, 6-months ]

Other Outcome Measures:
  1. Change from Baseline in Weight at 6 months [ Time Frame: baseline, 6-months ]
  2. Change from Baseline in C13 biomarker at 6 months [ Time Frame: baseline, 6-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193009


Locations
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United States, Virginia
Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise
Blacksburg, Virginia, United States, 24060
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
University of Kansas
University of Hawaii
Investigators
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Principal Investigator: Jamie M Zoellner, PhD, RD Virginia Polytechnic Institute and State University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jamie Zoellner, Associate Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT02193009    
Other Study ID Numbers: R01CA154364 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015