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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02193009
Other study ID # R01CA154364
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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