Dietary HabitsNCT02193009
SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages
A study testing SipSmarter and MoveMore in people with Dietary Habits and Physical Activity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Physical Activity
- What is being tested?
- SipSmarter and MoveMore
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Tech, Departmen of Human Nutrition, Foods, and Exercise
Blacksburg, Virginia, 24060
About this study
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).
Read the detailed description
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.
- Conditions
- Dietary Habits, Physical Activity
- Being tested
- SipSmarter, MoveMore
- Medical subject headings
- Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SipSmarterBehavioural
6-month behavioral trial
MoveMoreBehavioural
6 month behavioral trial
| Study group | Role | What they receive |
|---|---|---|
| SIPsmartER, behavioral intervention | Experimental | Aimed at decreasing sugar-sweetened beverage consumption Receives: Behavioral: SipSmarter |
| Move More, behavioral intervention | Active comparator | Aimed at physical activity promotion Receives: Behavioral: MoveMore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months
Measured: baseline, 6-months
Secondary outcomes (1)
Change from Baseline in Minutes of Physical Activity at 6 months
Measured: baseline, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas, University of Hawaii
- Responsible party
- Sponsor
- Investigators
- Jamie M Zoellner, PhD, RD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193009
- Sponsor's protocol ID
- R01CA154364
- Status last verified
- Apr 2022
- First submitted
- 11 Jul 2014
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30286755Kruzliakova 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.
PubMed 29421974Hedrick 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.
PubMed 28251935Estabrooks 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.
PubMed 28103935Zoellner 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.
PubMed 27000402Hedrick 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.
PubMed 25855120
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages
- ClinicalTrials.gov ID
- NCT02193009
- Acronym / sponsor ID
- R01CA154364
- Conditions
- Dietary Habits, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- University of Kansas, University of Hawaii
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIPsmartER, behavioral intervention | Experimental | Behavioral: SipSmarterAimed at decreasing sugar-sweetened beverage consumption |
| Move More, behavioral intervention | Active comparator | Behavioral: MoveMoreAimed at physical activity promotion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SipSmarter6-month behavioral trial | Behavioural | SIPsmartER, behavioral intervention |
| MoveMore6 month behavioral trial | Behavioural | Move More, behavioral intervention |
Primary outcome
Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months
Time frame: baseline, 6-months
1 secondary outcome
Change from Baseline in Minutes of Physical Activity at 6 months
Time frame: baseline, 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 30286755Zoellner 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.
- Derived from this study: PubMed 29421974Kruzliakova 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.
- Derived from this study: PubMed 28251935Hedrick 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.
- Derived from this study: PubMed 28103935Estabrooks 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.
- Derived from this study: PubMed 27000402Zoellner 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.
- Derived from this study: PubMed 25855120Hedrick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie M Zoellner, PhD, RD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SipSmarter and MoveMore in people with Dietary Habits and Physical Activity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months (time frame: baseline, 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193009, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.