ObesityNCT04289636
Self-compassion and Nutrition (SCAN) Study
A study testing Behavioral weight loss program, Self-compassion and Nutrition and cooking education in people with Obesity and Weight Loss, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility of two approaches for improving long-term weight loss success among individuals with severe obesity. All participants will receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a mindfulness self-compassion intervention or 8… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Behavioral weight loss program, Self-compassion and Nutrition and cooking education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 13 Jul 2021
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- BMI between 40 - 55 kg/m2
- Female
- Score high on internalized weight bias
Who cannot join
- Presence of any condition that would limit one's ability to exercise (i.e., orthopedic limitations)
- Recent weight loss (≥15 pounds within the past 6 months)
- History of bariatric surgery
- Current or recent enrollment (completed <1 year ago) in a weight loss program at the Weight Control and Diabetes Research Center
- Currently taking any weight loss or other medication that could alter one's metabolism
- Women who are pregnant, planning on becoming pregnant in the next 6 months, or those pregnant within the past 6 months
- Serious psychiatric disorder (e.g., psychosis, major depression, suicidality) -
- Participants with a history of diabetes or heart disease will be considered for this study only if their heart disease or diabetes is well controlled, and physician consent will be required.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Comparison of Two Approaches for Improving Long-term Weight Loss Among Individuals With Severe Obesity
The purpose of this study is to examine the feasibility of two approaches for improving long-term weight loss success among individuals with severe obesity. All participants will receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a mindfulness self-compassion intervention or 8 weeks of a nutrition and cooking education intervention (determined via randomization procedures). Assessments of weight, physical activity, and other weight-related and psychosocial factors will occur at baseline, 4 months, 6 months, and 9 months.
- Conditions
- Obesity, Weight Loss
- Being tested
- Behavioral weight loss program, Self-compassion, Nutrition and cooking education
- Keywords
- self-compassion, exercise, nutrition, physical activity
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight loss programBehavioural
Using a combination of individual (~1x/month) and group-based (~3x/month) meetings, participants will be taught behavioral approaches for changing diet and exercise behaviors. This intervention will be 15 weeks in duration and will be delivered remotely using a video-conferencing platform.
Self-compassionBehavioural
This 8-week, group-based program will help train individuals on how to handle difficult emotions with greater ease, how to transform difficult relationships, and how to motivate and encourage oneself, rather than being self-critical.
Nutrition and cooking educationBehavioural
This 8-week, group-based program will help individuals to improve the quality of their diet through nutrition education and basic cooking skills for preparing healthy meals.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss and self-compassion | Experimental | Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week mindfulness-based self-compassion program which combines the skills of mindfulness and self-compassion as a means for improving emotional resilience, well-being, and weight control. Receives: Behavioral: Behavioral weight loss program; Behavioral: Self-compassion |
| Weight loss and nutrition/cooking education | Active comparator | Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week nutrition and cooking education program which will provide basic nutrition knowledge and cooking skills for healthy eating. Receives: Behavioral: Behavioral weight loss program; Behavioral: Nutrition and cooking education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility will be assessed by the number of participants screened and enrolled
Recruitment feasibility will be assessed by the number of participants screened and enrolled
Measured: At the end of the study, up to 9 months post-baseline
Session attendance will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible).
The feasibility of the intervention will be assessed by calculating the overall session attendance
Measured: 6 months
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
Measured: 9 months
Secondary outcomes (2)
Percent weight change at 6 months
Measured: 6 months after study enrollment
Percent weight change at 9 months
Measured: 9 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Sep 2020
- Primary completion9 Apr 2021
- Study completion13 Jul 2021
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Unick, The Miriam Hospital
- Investigators
- Jessica L Unick, PhD, Principal investigator, The Miriam Hospital's Weight Control & Diabetes Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289636
- Sponsor's protocol ID
- 1569066
- Status last verified
- Aug 2021
- First submitted
- 27 Feb 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Approaches for Improving Long-term Weight Loss Among Individuals With Severe Obesity
- ClinicalTrials.gov ID
- NCT04289636
- Acronym / sponsor ID
- 1569066
- Conditions
- Obesity, Weight Loss
- Keywords
- self-compassion, exercise, nutrition, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 28 Feb 2020 (actual)
- 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 examine the feasibility of two approaches for improving long-term weight loss success among individuals with severe obesity. All participants will receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a mindfulness self-compassion intervention or 8 weeks of a nutrition and cooking education intervention (determined via randomization procedures). Assessments of weight, physical activity, and other weight-related and psychosocial factors will occur at baseline, 4 months, 6 months, and 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss and self-compassion | Experimental | Behavioral: Behavioral weight loss program, Behavioral: Self-compassionParticipants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week mindfulness-based self-compassion program which combines the skills of mindfulness and self-compassion as a means for improving emotional resilience, well-being, and weight control. |
| Weight loss and nutrition/cooking education | Active comparator | Behavioral: Behavioral weight loss program, Behavioral: Nutrition and cooking educationParticipants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week nutrition and cooking education program which will provide basic nutrition knowledge and cooking skills for healthy eating. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- BMI between 40 - 55 kg/m2
- Female
- Score high on internalized weight bias
Key exclusion criteria (8 listed)
- Presence of any condition that would limit one's ability to exercise (i.e., orthopedic limitations)
- Recent weight loss (≥15 pounds within the past 6 months)
- History of bariatric surgery
- Current or recent enrollment (completed <1 year ago) in a weight loss program at the Weight Control and Diabetes Research Center
- Currently taking any weight loss or other medication that could alter one's metabolism
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 |
|---|---|---|
| Behavioral weight loss programUsing a combination of individual (~1x/month) and group-based (~3x/month) meetings, participants will be taught behavioral approaches for changing diet and exercise behaviors. This intervention will be 15 weeks in duration and will be delivered remotely using a video-conferencing platform. | Behavioural | Weight loss and nutrition/cooking education, Weight loss and self-compassion |
| Self-compassionThis 8-week, group-based program will help train individuals on how to handle difficult emotions with greater ease, how to transform difficult relationships, and how to motivate and encourage oneself, rather than being self-critical. | Behavioural | Weight loss and self-compassion |
| Nutrition and cooking educationThis 8-week, group-based program will help individuals to improve the quality of their diet through nutrition education and basic cooking skills for preparing healthy meals. | Behavioural | Weight loss and nutrition/cooking education |
Primary outcome
Recruitment feasibility will be assessed by the number of participants screened and enrolled
Time frame: At the end of the study, up to 9 months post-baseline
Recruitment feasibility will be assessed by the number of participants screened and enrolled
Session attendance will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible).
Time frame: 6 months
The feasibility of the intervention will be assessed by calculating the overall session attendance
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
Time frame: 9 months
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
2 secondary outcomes
Percent weight change at 6 months
Time frame: 6 months after study enrollment
Percent weight change at 9 months
Time frame: 9 months after study 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 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Jessica L Unick, PhD principal investigator
The Miriam Hospital's Weight Control & Diabetes Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral weight loss program, Self-compassion and Nutrition and cooking education in people with Obesity and Weight Loss, run by The Miriam Hospital 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 4 inclusion and 8 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 31 Aug 2021. 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?
Recruitment feasibility will be assessed by the number of participants screened and enrolled (time frame: At the end of the study, up to 9 months post-baseline). The study lists 3 primary outcomes in all. 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 31 Aug 2021.