ObesityNCT01017783
Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
A study testing Dietary substitution A, Dietary Substitution B and Healthy Choices in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary substitution A, Dietary Substitution B and Healthy Choices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2010
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age.
- Body mass index (BMI) between 25.0-49.9 kg/m2.
- Subject consumes at least 280 calories per day from caloric beverages.
Who cannot join
- Report losing >5% of current body weight in the previous 6 months.
- Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
- Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
- Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
- Report hospitalization for psychiatric problems during the prior year.
- Report major psychiatric diagnoses and organic brain syndromes.
Show all 13Show fewer
- Report heart problems, chest pain, cancer within the last 5 years
- Being treated by a therapist for psychological issues or problems with psychotropic medications.
- Report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4-QF) (Cherpitel CJ, 2002).
- Unwilling to change intake of beverages during the study period.
- Plan to move from the area during the study period, and/or unable to attend monthly group meetings.
- Report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home.
- Report not being able to attend group meetings on Monday or Tuesday evenings.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7294
About this study
Official title: Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.
The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.
- Conditions
- Obesity
- Being tested
- Dietary substitution A, Dietary Substitution B, Healthy Choices
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary substitution ABehavioural
Substitution of calorie-dense item with lower calorie choice A
Dietary Substitution BBehavioural
Substitution of calorie-dense item with lower calorie option B
Healthy ChoicesBehavioural
Multiple healthy choices presented with self-selection of choices used
| Study group | Role | What they receive |
|---|---|---|
| Healthy Choices | Other | Not described Receives: Behavioral: Healthy Choices |
| Diet Substitution A | Experimental | Not described Receives: Behavioral: Dietary substitution A |
| Diet Substitution B | Experimental | Not described Receives: Behavioral: Dietary Substitution B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measured: 0, 3, 6 months
Secondary outcomes (2)
urine specific gravity
Measured: 0, 3, 6 months
fasting glucose
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Nestle Waters North America, Inc
- Investigators
- Deborah F Tate, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017783
- Sponsor's protocol ID
- UNC-Nestle-01
- Status last verified
- Aug 2011
- First submitted
- 19 Nov 2009
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Piernas C, Tate DF, Wang X, Popkin BM. Does diet-beverage intake affect dietary consumption patterns? Results from the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2013 Mar;97(3):604-11. doi: 10.3945/ajcn.112.048405. Epub 2013 Jan 30.
PubMed 23364015Tate DF, Turner-McGrievy G, Lyons E, Stevens J, Erickson K, Polzien K, Diamond M, Wang X, Popkin B. Replacing caloric beverages with water or diet beverages for weight loss in adults: main results of the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2012 Mar;95(3):555-63. doi: 10.3945/ajcn.111.026278. Epub 2012 Feb 1.
PubMed 22301929
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
- ClinicalTrials.gov ID
- NCT01017783
- Acronym / sponsor ID
- UNC-Nestle-01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Nestle Waters North America, Inc
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Nov 2009 (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 objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.
The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Choices | Other | Behavioral: Healthy Choices |
| Diet Substitution A | Experimental | Behavioral: Dietary substitution A |
| Diet Substitution B | Experimental | Behavioral: Dietary Substitution B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of age.
- Body mass index (BMI) between 25.0-49.9 kg/m2.
- Subject consumes at least 280 calories per day from caloric beverages.
Key exclusion criteria (13 listed)
- Report losing >5% of current body weight in the previous 6 months.
- Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
- Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
- Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
- Report hospitalization for psychiatric problems during the prior year.
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 |
|---|---|---|
| Dietary substitution ASubstitution of calorie-dense item with lower calorie choice A | Behavioural | Diet Substitution A |
| Dietary Substitution BSubstitution of calorie-dense item with lower calorie option B | Behavioural | Diet Substitution B |
| Healthy ChoicesMultiple healthy choices presented with self-selection of choices used | Behavioural | Healthy Choices |
Primary outcome
Weight change
Time frame: 0, 3, 6 months
2 secondary outcomes
urine specific gravity
Time frame: 0, 3, 6 months
fasting glucose
Time frame: 0, 3, 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 3 Aug 2011.
- Derived from this study: PubMed 23364015Piernas C, Tate DF, Wang X, Popkin BM. Does diet-beverage intake affect dietary consumption patterns? Results from the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2013 Mar;97(3):604-11. doi: 10.3945/ajcn.112.048405. Epub 2013 Jan 30.
- Derived from this study: PubMed 22301929Tate DF, Turner-McGrievy G, Lyons E, Stevens J, Erickson K, Polzien K, Diamond M, Wang X, Popkin B. Replacing caloric beverages with water or diet beverages for weight loss in adults: main results of the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2012 Mar;95(3):555-63. doi: 10.3945/ajcn.111.026278. Epub 2012 Feb 1.
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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.
Deborah F Tate, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary substitution A, Dietary Substitution B and Healthy Choices in people with Obesity, run by University of North Carolina, Chapel Hill 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 3 inclusion and 13 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 3 Aug 2011. 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?
Weight change (time frame: 0, 3, 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 NCT01017783, which also lists 2 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 3 Aug 2011.