OverweightNCT00558194
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)
A study testing Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training and Standard Behavioral Weight Loss Treatment in people with Overweight and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training and Standard Behavioral Weight Loss Treatment
- 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
- Aug 2009to Jan 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 70 years
- Body mass index between 27 and 40
- Score 5 or above on the internal disinhibition scale of the Eating Inventory
Who cannot join
- Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
- Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Weight Control and Diabetes Research Center, The Miriam Hospital
Providence, Rhode Island, 02903
About this study
Official title: Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.
- Conditions
- Overweight, Obesity
- Being tested
- Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training, Standard Behavioral Weight Loss Treatment
- Keywords
- Weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills TrainingBehavioural
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
Standard Behavioral Weight Loss TreatmentBehavioural
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard behavioral weight loss treatment with cognitive and affective skills training Receives: Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training |
| 2 | Active comparator | Standard behavioral weight loss treatment Receives: Behavioral: Standard Behavioral Weight Loss Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 12 Months
Secondary outcomes (3)
Internal disinhibition as measured by the Eating Inventory
Measured: 12 Months
Physical activity as measured by the Paffenbarger
Measured: 12 months
Dietary intake as measured by the Block Food Frequency Questionnaire
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 posted14 Nov 2007 (estimated)
- Study startAug 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Heather M. Niemeier, Ph.D., Principal investigator, The Miriam Hospital/The Warren Alpert Medical School of Brown U niversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558194
- Sponsor's protocol ID
- K23 DK73536-2
- Other IDs
- K23DK073536
- Status last verified
- Mar 2018
- First submitted
- 13 Nov 2007
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT00558194
- Acronym / sponsor ID
- K23 DK73536-2
- Conditions
- Overweight, Obesity
- Keywords
- Weight loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 14 Nov 2007 (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.
Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills TrainingStandard behavioral weight loss treatment with cognitive and affective skills training |
| 2 | Active comparator | Behavioral: Standard Behavioral Weight Loss TreatmentStandard behavioral weight loss treatment |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 21 and 70 years
- Body mass index between 27 and 40
- Score 5 or above on the internal disinhibition scale of the Eating Inventory
Key exclusion criteria (3 listed)
- Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
- Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
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 Weight Loss Treatment with Affective and Cognitive Skills Training12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment | Behavioural | 1 |
| Standard Behavioral Weight Loss Treatment12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment | Behavioural | 2 |
Primary outcome
Weight Loss
Time frame: 12 Months
3 secondary outcomes
Internal disinhibition as measured by the Eating Inventory
Time frame: 12 Months
Physical activity as measured by the Paffenbarger
Time frame: 12 months
Dietary intake as measured by the Block Food Frequency Questionnaire
Time frame: 12 months
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 14 Mar 2018.
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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.
Heather M. Niemeier, Ph.D. principal investigator
The Miriam Hospital/The Warren Alpert Medical School of Brown U niversity
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 Weight Loss Treatment with Affective and Cognitive Skills Training and Standard Behavioral Weight Loss Treatment in people with Overweight and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 14 Mar 2018. 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 Loss (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2018.