SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages

Physical Activity Clinical Trial

Official title:

SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193009
• Other study ID #: R01CA154364
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2022
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Habits
• Physical Activity

Intervention

Behavioral:
• SipSmarter
6-month behavioral trial
• MoveMore
6 month behavioral trial

Locations

Country	Name	City	State
United States	Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise	Blacksburg	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	University of Hawaii, University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in Weight at 6 months		baseline, 6-months
Other	Change from Baseline in C13 biomarker at 6 months		baseline, 6-months
Primary	Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months		baseline, 6-months
Secondary	Change from Baseline in Minutes of Physical Activity at 6 months		baseline, 6-months

External Links

•   Methods paper