OverweightSELFNCT00896194
Self-Efficacy in Weight Loss Treatment
A study testing Standard Behavioral Treatment and Modified Standard Behavioral Intervention + Self-Efficacy in people with Overweight and Obesity, run by Lora Burke at 1 site in United States.
Trial summary
This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Standard Behavioral Treatment and Modified Standard Behavioral Intervention + Self-Efficacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Apr 2013
- 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
- age 18 years or older
- BMI > 27 and < 43
- willing to be randomized to one of the two treatment conditions
- successful completion of screening requiring 5-day recording of food intake in a paper diary
- have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative)
- NOTE: Although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently (weekly for the first month)
Who cannot join
- presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed
- physical limitations precluding ability to engage in physical activity at moderate intensity
- pregnancy or intention to become pregnant in the next 18 months
- current treatment for a psychological disorder
- reported alcohol intake > 4 drinks/day
- previous participation in a formal weight loss program within the past 5 years, e.g., Weight Watchers or a research program, or current use of weight loss medication
- planned extended vacations, absences, or relocation within the next 18 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261
About this study
This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol.
Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:
Read more
- every week during the first month of the study,
- every other week for the second month
- once a month for months 3-12
- every 6 weeks for months 13-18
Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.
Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.
- Conditions
- Overweight, Obesity
- Being tested
- Standard Behavioral Treatment, Modified Standard Behavioral Intervention + Self-Efficacy
- Keywords
- Overweight, Obesity, Self-Efficacy, Treatment Adherence
- Medical subject headings
- Overweight, Obesity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Behavioral TreatmentBehavioural
SBT consists of group counseling sessions where participants learn about healthy eating and physical activity. Participants are also given standard calorie goals, fat gram goals, and physical activity goals (minutes).
Modified Standard Behavioral Intervention + Self-EfficacyBehavioural
This group receives identical group intervention sessions. The goals (calories, fat grams, and physical activity minutes) are tailored to the individual's progress. Participants meet regularly with an interventionist for one-on-one lifestyle counseling.
| Study group | Role | What they receive |
|---|---|---|
| 1: Standard Behavioral Treatment (SBT) | Active comparator | This group receives standard behavioral treatment for weight loss as described below. Receives: Behavioral: Standard Behavioral Treatment |
| 2: Modified SBT + Self-Efficacy | Experimental | This group receives modified SBT with an additional self-efficacy component as described below. Receives: Behavioral: Modified Standard Behavioral Intervention + Self-Efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 12 and 18 months post enrollment
Secondary outcomes (2)
Health-related quality of life
Measured: 12 and 18 months post enrollment
Adherence to treatment protocol
Measured: 12 and 18 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2013
- Study completionApr 2013
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 OverweightStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lora Burke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lora Burke, University of Pittsburgh
- Investigators
- Lora E. Burke, PhD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896194
- Sponsor's protocol ID
- P01NR010949-PRO08050004
- Other IDs
- P01NR010949
- Acronym
- SELF
- Status last verified
- Jul 2015
- First submitted
- 7 May 2009
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Imes CC, Zheng Y, Mendez DD, Rockette-Wagner BJ, Mattos MK, Goode RW, Sereika SM, Burke LE. Group-Based Trajectory Analysis of Physical Activity Change in a US Weight Loss Intervention. J Phys Act Health. 2018 Nov 1;15(11):840-846. doi: 10.1123/jpah.2017-0484. Epub 2018 Oct 12.
PubMed 30314417Zheng Y, Sereika SM, Ewing LJ, Danford CA, Terry MA, Burke LE. Association between Self-Weighing and Percent Weight Change: Mediation Effects of Adherence to Energy Intake and Expenditure Goals. J Acad Nutr Diet. 2016 Apr;116(4):660-6. doi: 10.1016/j.jand.2015.10.014. Epub 2015 Dec 25.
PubMed 26727241Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.
PubMed 26609668
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Efficacy in Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT00896194
- Acronym / sponsor ID
- SELF / P01NR010949-PRO08050004
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Self-Efficacy, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lora BurkeUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 May 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.
This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol.
Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:
- every week during the first month of the study,
- every other week for the second month
- once a month for months 3-12
- every 6 weeks for months 13-18
Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.
Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Standard Behavioral Treatment (SBT) | Active comparator | Behavioral: Standard Behavioral TreatmentThis group receives standard behavioral treatment for weight loss as described below. |
| 2: Modified SBT + Self-Efficacy | Experimental | Behavioral: Modified Standard Behavioral Intervention + Self-EfficacyThis group receives modified SBT with an additional self-efficacy component as described below. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or older
- BMI > 27 and < 43
- willing to be randomized to one of the two treatment conditions
- successful completion of screening requiring 5-day recording of food intake in a paper diary
- have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative)
Key exclusion criteria (7 listed)
- presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed
- physical limitations precluding ability to engage in physical activity at moderate intensity
- pregnancy or intention to become pregnant in the next 18 months
- current treatment for a psychological disorder
- reported alcohol intake > 4 drinks/day
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 |
|---|---|---|
| Standard Behavioral TreatmentSBT consists of group counseling sessions where participants learn about healthy eating and physical activity. Participants are also given standard calorie goals, fat gram goals, and physical activity goals (minutes). | Behavioural | 1: Standard Behavioral Treatment (SBT) |
| Modified Standard Behavioral Intervention + Self-EfficacyThis group receives identical group intervention sessions. The goals (calories, fat grams, and physical activity minutes) are tailored to the individual's progress. Participants meet regularly with an interventionist for one-on-one lifestyle counseling. | Behavioural | 2: Modified SBT + Self-Efficacy |
Primary outcome
Weight
Time frame: 12 and 18 months post enrollment
2 secondary outcomes
Health-related quality of life
Time frame: 12 and 18 months post enrollment
Adherence to treatment protocol
Time frame: 12 and 18 months post enrollment
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 7 Jul 2015.
- Derived from this study: PubMed 30314417Imes CC, Zheng Y, Mendez DD, Rockette-Wagner BJ, Mattos MK, Goode RW, Sereika SM, Burke LE. Group-Based Trajectory Analysis of Physical Activity Change in a US Weight Loss Intervention. J Phys Act Health. 2018 Nov 1;15(11):840-846. doi: 10.1123/jpah.2017-0484. Epub 2018 Oct 12.
- Derived from this study: PubMed 26727241Zheng Y, Sereika SM, Ewing LJ, Danford CA, Terry MA, Burke LE. Association between Self-Weighing and Percent Weight Change: Mediation Effects of Adherence to Energy Intake and Expenditure Goals. J Acad Nutr Diet. 2016 Apr;116(4):660-6. doi: 10.1016/j.jand.2015.10.014. Epub 2015 Dec 25.
- Derived from this study: PubMed 26609668Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.
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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.
Lora E. Burke, PhD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Behavioral Treatment and Modified Standard Behavioral Intervention + Self-Efficacy in people with Overweight and Obesity, run by Lora Burke 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 6 inclusion and 7 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 7 Jul 2015. 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 (time frame: 12 and 18 months post enrollment). 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 NCT00896194, 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 7 Jul 2015; AzTrials last refreshed its copy on 3 Nov 2026.