ObesityImWeLNCT02487121
Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
A study testing variable interval schedule and self-directed treatment in people with Obesity, run by University of Alabama at Birmingham.
Trial summary
This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- variable interval schedule and self-directed treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Mar 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 21 years-old
- body mass index (BMI) = 28.0 - 45.0 kg/m2
- willing to provide informed consent and accept randomization
Who cannot join
- BMI >45 kg/m2
- Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
- Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.
About this study
This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.
- Conditions
- Obesity
- Being tested
- variable interval schedule, self-directed treatment
- Keywords
- weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
variable interval scheduleBehavioural
12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
self-directed treatmentBehavioural
provision of treatment materials with instruction to work through materials at participant's own pace
| Study group | Role | What they receive |
|---|---|---|
| variable interval schedule | Experimental | 12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period Receives: Behavioral: variable interval schedule |
| self-directed treatment | Active comparator | provision of treatment materials with instruction to work through materials at participant's own pace Receives: Behavioral: self-directed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight (kg)
change in body weight (kg) between randomization and month-12 follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startApr 2010
- Primary completionMar 2015
- Study completionMar 2015
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 Alabama at BirminghamThe 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gareth R. Dutton PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487121
- Sponsor's protocol ID
- K23DK081607
- Acronym
- ImWeL
- Status last verified
- Jun 2015
- First submitted
- 26 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schneider-Worthington CR, Kinsey AW, Tan F, Zhang S, Borgatti AC, Davis AL, Dutton GR. Pretreatment and During-Treatment Weight Trajectories in Black and White Women. Am J Prev Med. 2022 Jul;63(1 Suppl 1):S67-S74. doi: 10.1016/j.amepre.2022.01.031.
PubMed 35725143Dutton GR, Gowey MA, Tan F, Zhou D, Ard J, Perri MG, Lewis CE. Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Int J Behav Nutr Phys Act. 2017 Aug 15;14(1):107. doi: 10.1186/s12966-017-0564-1.
PubMed 28806992
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
- ClinicalTrials.gov ID
- NCT02487121
- Acronym / sponsor ID
- ImWeL / K23DK081607
- Conditions
- Obesity
- Keywords
- weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Jul 2015 (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.
This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| variable interval schedule | Experimental | Behavioral: variable interval schedule12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period |
| self-directed treatment | Active comparator | Behavioral: self-directed treatmentprovision of treatment materials with instruction to work through materials at participant's own pace |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 21 years-old
- body mass index (BMI) = 28.0 - 45.0 kg/m2
- willing to provide informed consent and accept randomization
Key exclusion criteria (3 listed)
- BMI >45 kg/m2
- Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
- Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.
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 |
|---|---|---|
| variable interval schedule12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period | Behavioural | variable interval schedule |
| self-directed treatmentprovision of treatment materials with instruction to work through materials at participant's own pace | Behavioural | self-directed treatment |
Primary outcome
body weight (kg)
Time frame: 12 months
change in body weight (kg) between randomization and month-12 follow-up
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 1 Jul 2015.
- Derived from this study: PubMed 35725143Schneider-Worthington CR, Kinsey AW, Tan F, Zhang S, Borgatti AC, Davis AL, Dutton GR. Pretreatment and During-Treatment Weight Trajectories in Black and White Women. Am J Prev Med. 2022 Jul;63(1 Suppl 1):S67-S74. doi: 10.1016/j.amepre.2022.01.031.
- Derived from this study: PubMed 28806992Dutton GR, Gowey MA, Tan F, Zhou D, Ard J, Perri MG, Lewis CE. Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Int J Behav Nutr Phys Act. 2017 Aug 15;14(1):107. doi: 10.1186/s12966-017-0564-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing variable interval schedule and self-directed treatment in people with Obesity, run by University of Alabama at Birmingham.
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: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
body weight (kg) (time frame: 12 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 NCT02487121, 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 1 Jul 2015.