SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages

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).

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jamie M Zoellner, PhD, RD, Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

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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