ObesityNCT02198196
Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs
A study testing Weight Talk-Mindfulness in people with Obesity, run by Consumer Wellness Solutions at 1 site in United States.
Trial summary
The purpose of this study is to explore the efficacy of a phone-based weight loss program that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The program is targeted at employees of certain companies who meet a cut-off score on a measure of stress-related eating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Weight Talk-Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jan 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be enrolled in the Weight Talk program, inclusion criteria:
- Employment by one of the employers who contract for Weight Talk services
- Being over 18 years of age
- Speak and read English
- Have a starting BMI between 25 and 35.
- Score 5 or higher on the 8-item Internal Disinhibition subscale of the Eating Inventory.
- Have regular access to email and internet.
- Willingness and ability to complete study and intervention procedures, including completing assessments, engaging in moderate physical activity (e.g., walking, swimming) and using the electronic scale at least once per week.
Who cannot join
- Type 2 Diabetes (Type 1 is an exclusion for the Weight Talk program).
- Past diagnosis of anorexia nervosa or bulimia nervosa.
- Weight Talk program exclusion criteria include:
- Pregnancy
- Bariatric surgery within past 12 months or planned in the next 6 months
- Undergoing dialysis
Show all 9Show fewer
- Have Type 1 Diabetes diagnosis
- Women who are pregnant are not eligible for the program, but contraception is not required as this is a low risk study
- Currently using or planning to start using a pharmaceutical weight loss drug
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the efficacy of a phone-based weight loss program that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The program is targeted at employees of certain companies who meet a cut-off score on a measure of stress-related eating. The control group will receive a standard phone-based program with no additional stress management information (Weight Talk-Standard).
- Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience decreases in their stress-related \& emotion-related eating compared to the Weight Talk-Standard (WT-S; n=25) group.
- Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.
- Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased eating self-efficacy, increased acceptance of weight-related thoughts \& feelings and increased mindfulness compared to those in the WT-S control arm.
- Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss program as those in WT-S.
- Conditions
- Obesity
- Being tested
- Weight Talk-Mindfulness
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Talk-MindfulnessBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Weight Talk-Mindfulness | Experimental | WT-M retain the evidence-based elements of WT-S (control condition), including the DASH diet, physical activity components, and an emphasis on self-monitoring. However, each call in WT-M will include an emphasis on mindfulness and stress management that will not be included in the control condition. Receives: Behavioral: Weight Talk-Mindfulness |
| Weight Talk-Standard | No intervention | Weight Talk-Standard is a phone and web-based weight loss intervention offered by employers as a benefit to their employees. Weight Talk is based on the NIH Clinical Guidelines on Identification, Evaluation and Treatment of Overweight and Obesity in Adults and utilizes the curriculum developed for the Diabetes Prevention Program. Weight Talk-S contains no additional stress management techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Inventory - Internal Disinhibition subscale
8 items, screens for emotion and stress-related eating habits
Measured: Screening and 6-month follow-up
Secondary outcomes (1)
Body weight
Weight in pounds
Measured: Screening and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consumer Wellness Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee Alekel, PhD, Study chair, National Center for Complementary and Integrative Health (NCCIH)Kelly Carpenter, PhD, Principal investigator, Consumer Wellness SolutionsJennifer Lovejoy, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198196
- Sponsor's protocol ID
- 1R21AT007845-01A1
- Status last verified
- Feb 2016
- First submitted
- 21 Jul 2014
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs
- ClinicalTrials.gov ID
- NCT02198196
- Acronym / sponsor ID
- 1R21AT007845-01A1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Consumer Wellness SolutionsIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jul 2014 (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 purpose of this study is to explore the efficacy of a phone-based weight loss program that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The program is targeted at employees of certain companies who meet a cut-off score on a measure of stress-related eating. The control group will receive a standard phone-based program with no additional stress management information (Weight Talk-Standard).
- Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience decreases in their stress-related \& emotion-related eating compared to the Weight Talk-Standard (WT-S; n=25) group.
- Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.
- Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased eating self-efficacy, increased acceptance of weight-related thoughts \& feelings and increased mindfulness compared to those in the WT-S control arm.
- Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss program as those in WT-S.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Talk-Mindfulness | Experimental | Behavioral: Weight Talk-MindfulnessWT-M retain the evidence-based elements of WT-S (control condition), including the DASH diet, physical activity components, and an emphasis on self-monitoring. However, each call in WT-M will include an emphasis on mindfulness and stress management that will not be included in the control condition. |
| Weight Talk-Standard | No intervention | –Weight Talk-Standard is a phone and web-based weight loss intervention offered by employers as a benefit to their employees. Weight Talk is based on the NIH Clinical Guidelines on Identification, Evaluation and Treatment of Overweight and Obesity in Adults and utilizes the curriculum developed for the Diabetes Prevention Program. Weight Talk-S contains no additional stress management techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be enrolled in the Weight Talk program, inclusion criteria:
- Have a starting BMI between 25 and 35.
- Score 5 or higher on the 8-item Internal Disinhibition subscale of the Eating Inventory.
- Have regular access to email and internet.
- Willingness and ability to complete study and intervention procedures, including completing assessments, engaging in moderate physical activity (e.g., walking, swimming) and using the electronic scale at least once per week.
Key exclusion criteria (9 listed)
- Type 2 Diabetes (Type 1 is an exclusion for the Weight Talk program).
- Past diagnosis of anorexia nervosa or bulimia nervosa.
- Weight Talk program exclusion criteria include:
- Women who are pregnant are not eligible for the program, but contraception is not required as this is a low risk study
- Currently using or planning to start using a pharmaceutical weight loss drug
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 |
|---|---|---|
| Weight Talk-Mindfulness | Behavioural | Weight Talk-Mindfulness |
Primary outcome
Eating Inventory - Internal Disinhibition subscale
Time frame: Screening and 6-month follow-up
8 items, screens for emotion and stress-related eating habits
1 secondary outcome
Body weight
Time frame: Screening and 6-month 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 5 Feb 2016.
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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.
Lee Alekel, PhD study chair
National Center for Complementary and Integrative Health (NCCIH)
Kelly Carpenter, PhD principal investigator
Consumer Wellness Solutions
Jennifer Lovejoy, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Talk-Mindfulness in people with Obesity, run by Consumer Wellness Solutions 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 8 inclusion and 9 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 5 Feb 2016. 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?
Eating Inventory - Internal Disinhibition subscale (time frame: Screening and 6-month follow-up). 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 5 Feb 2016.