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OpenTrials
Completed

NCT Number: NCT02193009

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise

Blacksburg, Virginia, 24060, United States

About this study

The primary aim of this application targeting at-risk residents from rural southwest Virginia counties is to:

  • 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:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SipSmarter

Behavioral

6-month behavioral trial

MoveMore

Behavioral

6 month behavioral trial

Primary outcomes

  1. Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months

    Time frame: baseline, 6-months

Secondary outcomes

  1. Change from Baseline in Minutes of Physical Activity at 6 months

    Time frame: baseline, 6-months

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • University of Hawaii
  • University of Kansas

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2014
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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