WeightNCT01693913
Cognitive-behavioral Weight Loss Treatment
A study testing cognitive behavioral exercise and nutrition over and nutrition and exercise education in people with Weight, run by YMCA of Metropolitan Atlanta at 1 site in United States.
Trial summary
That a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight
- What is being tested?
- cognitive behavioral exercise and nutrition over and nutrition and exercise education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2014
- 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 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Ages 21-60
- Body mass index 30-40 kg/m2
Who cannot join
- Pregnancy
- Medications for a psychological disorder
- Contraindications for exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Cognitive-behavioral Weight Loss Treatment
That a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education.
- Conditions
- Weight
- Being tested
- cognitive behavioral exercise and nutrition over, nutrition and exercise education
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral exercise and nutrition overBehavioural
nutrition and exercise educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral | Experimental | Those participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks Receives: Behavioral: cognitive behavioral exercise and nutrition over |
| Nurtition education | Active comparator | This arm will participate in nutrition and exercise education Receives: Behavioral: nutrition and exercise education |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Direct measurement of weight
Measured: baseline, months 3,6,12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: IRB approval canceled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for WeightStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- YMCA of Metropolitan Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James J Annesi, PhD, Principal investigator, YMCA of Metro Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693913
- Sponsor's protocol ID
- YMCAAtlantaWeightLoss
- Status last verified
- Dec 2013
- First submitted
- 21 Sep 2012
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Annesi JJ. Supported exercise improves controlled eating and weight through its effects on psychosocial factors: extending a systematic research program toward treatment development. Perm J. 2012 Winter;16(1):7-18. doi: 10.7812/11-136.
PubMed 22529754Annesi JJ, Marti CN. Path analysis of exercise treatment-induced changes in psychological factors leading to weight loss. Psychol Health. 2011 Aug;26(8):1081-98. doi: 10.1080/08870446.2010.534167. Epub 2011 Jul 25.
PubMed 21780982Annesi JJ, Unruh JL, Marti CN, Gorjala S, Tennant G. Effects of the coach approach intervention on adherence to exercise in obese women: assessing mediation of social cognitive theory factors. Res Q Exerc Sport. 2011 Mar;82(1):99-108. doi: 10.1080/02701367.2011.10599726.
PubMed 21462690
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cognitive-behavioral Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT01693913
- Acronym / sponsor ID
- YMCAAtlantaWeightLoss
- Conditions
- Weight
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB approval canceled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- YMCA of Metropolitan AtlantaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 26 Sep 2012 (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.
That a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral | Experimental | Behavioral: cognitive behavioral exercise and nutrition overThose participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks |
| Nurtition education | Active comparator | Behavioral: nutrition and exercise educationThis arm will participate in nutrition and exercise education |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Ages 21-60
- Body mass index 30-40 kg/m2
Key exclusion criteria (3 listed)
- Pregnancy
- Medications for a psychological disorder
- Contraindications for exercise
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 |
|---|---|---|
| cognitive behavioral exercise and nutrition over | Behavioural | Cognitive-behavioral |
| nutrition and exercise education | Behavioural | Nurtition education |
Primary outcome
weight
Time frame: baseline, months 3,6,12, 24
Direct measurement of weight
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Background: PubMed 22529754Annesi JJ. Supported exercise improves controlled eating and weight through its effects on psychosocial factors: extending a systematic research program toward treatment development. Perm J. 2012 Winter;16(1):7-18. doi: 10.7812/11-136.
- Background: PubMed 21780982Annesi JJ, Marti CN. Path analysis of exercise treatment-induced changes in psychological factors leading to weight loss. Psychol Health. 2011 Aug;26(8):1081-98. doi: 10.1080/08870446.2010.534167. Epub 2011 Jul 25.
- Background: PubMed 21462690Annesi JJ, Unruh JL, Marti CN, Gorjala S, Tennant G. Effects of the coach approach intervention on adherence to exercise in obese women: assessing mediation of social cognitive theory factors. Res Q Exerc Sport. 2011 Mar;82(1):99-108. doi: 10.1080/02701367.2011.10599726.
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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.
James J Annesi, PhD principal investigator
YMCA of Metro Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral exercise and nutrition over and nutrition and exercise education in people with Weight, run by YMCA of Metropolitan Atlanta 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 3 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: withdrawn, as of the sponsor's last update on 31 Dec 2013. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: baseline, months 3,6,12, 24). 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 NCT01693913, which also lists 3 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 31 Dec 2013.