NCT02193009

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

4.4 years

First QC Date

July 11, 2014

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

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

    baseline, 6-months

Secondary Outcomes (1)

  • Change from Baseline in Minutes of Physical Activity at 6 months

    baseline, 6-months

Other Outcomes (2)

  • Change from Baseline in Weight at 6 months

    baseline, 6-months

  • Change from Baseline in C13 biomarker at 6 months

    baseline, 6-months

Study Arms (2)

SIPsmartER, behavioral intervention

EXPERIMENTAL

Aimed at decreasing sugar-sweetened beverage consumption

Behavioral: SipSmarter

Move More, behavioral intervention

ACTIVE COMPARATOR

Aimed at physical activity promotion

Behavioral: MoveMore

Interventions

SipSmarterBEHAVIORAL

6-month behavioral trial

SIPsmartER, behavioral intervention
MoveMoreBEHAVIORAL

6 month behavioral trial

Move More, behavioral intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Blacksburg, Virginia, 24060, United States

Location

Related Publications (6)

  • Zoellner JM, You W, Estabrooks PA, Chen Y, Davy BM, Porter KJ, Hedrick VE, Bailey A, Kruzliakova N. Supporting maintenance of sugar-sweetened beverage reduction using automated versus live telephone support: findings from a randomized control trial. Int J Behav Nutr Phys Act. 2018 Oct 4;15(1):97. doi: 10.1186/s12966-018-0728-7.

  • Kruzliakova N, Estabrooks PA, You W, Hedrick V, Porter K, Kiernan M, Zoellner J. The Relationship Between the Stanford Leisure-Time Activity Categorical Item and the Godin Leisure-Time Exercise Questionnaire Among Rural Intervention Participants of Varying Health Literacy Status. J Phys Act Health. 2018 Apr 1;15(4):269-278. doi: 10.1123/jpah.2017-0284. Epub 2018 Feb 9.

  • Hedrick VE, Davy BM, You W, Porter KJ, Estabrooks PA, Zoellner JM. Dietary quality changes in response to a sugar-sweetened beverage-reduction intervention: results from the Talking Health randomized controlled clinical trial. Am J Clin Nutr. 2017 Apr;105(4):824-833. doi: 10.3945/ajcn.116.144543. Epub 2017 Mar 1.

  • Estabrooks P, You W, Hedrick V, Reinholt M, Dohm E, Zoellner J. A pragmatic examination of active and passive recruitment methods to improve the reach of community lifestyle programs: The Talking Health Trial. Int J Behav Nutr Phys Act. 2017 Jan 19;14(1):7. doi: 10.1186/s12966-017-0462-6.

  • Zoellner JM, Hedrick VE, You W, Chen Y, Davy BM, Porter KJ, Bailey A, Lane H, Alexander R, Estabrooks PA. Effects of a behavioral and health literacy intervention to reduce sugar-sweetened beverages: a randomized-controlled trial. Int J Behav Nutr Phys Act. 2016 Mar 22;13:38. doi: 10.1186/s12966-016-0362-1.

  • Hedrick VE, Zoellner JM, Jahren AH, Woodford NA, Bostic JN, Davy BM. A Dual-Carbon-and-Nitrogen Stable Isotope Ratio Model Is Not Superior to a Single-Carbon Stable Isotope Ratio Model for Predicting Added Sugar Intake in Southwest Virginian Adults. J Nutr. 2015 Jun;145(6):1362-9. doi: 10.3945/jn.115.211011. Epub 2015 Apr 8.

MeSH Terms

Conditions

Feeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Jamie M Zoellner, PhD, RD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 17, 2014

Study Start

July 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations