Bariatric Surgery Candidate, Eating Behavior, Obesity, Weight Gain, Weight Loss
Conditions
Keywords
Appetite Regulation, Weight regain prevention, Weight loss maintenance, mindfulness, mindfulness orientated recovery enhancement
Brief summary
The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.
Detailed description
Specific Aim 1: Determine the effect of MORE on weight loss maintenance. Hypothesis: MORE will result in less weight regain compared to CON after the 8-week intervention, and benefits will be sustained after 6-month of follow-up. Specific Aim 2: Determine the effect of MORE on reward-related behavioral processes (e.g., disinhibition, restraint, hedonic hunger). Hypothesis: MORE group will demonstrate changes in eating behaviors associated with preventing weight regain compared to CON immediately after MORE and after 6-months of follow-up.
Interventions
BEHAVIORALMindfulness Orientated Recovery Enhancement
The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing.
BEHAVIORALControl Intervention
The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-65 * Bariatric Surgery patients: 12-18 months post-operation. * Medical weight loss patients: patients of the bariatric weight loss clinic, weight loss of 7% body mass via intentional weight loss within past 6 months; BMI \>25 kg/m2 prior to intentional weight loss; stable for 3 months on medications. * Lifestyle weight loss: weight loss of 7% body mass via intentional weight loss within past 6 months; BMI \>25 kg/m2 prior to intentional weight loss.
Exclusion criteria
* Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; cancer treatment in past 5 years; untreated thyroid disease or other medical condition affecting weight or energy metabolism; severe food allergies; women who are pregnant, lactating, or planning pregnancy during participation in the trial; active psychiatric issues * Additional criteria specific to patients with history of bariatric surgery: \<12 months post-op; weight regain of \>5% of body mass postoperation; history of admittance to rehabilitation facility; history of post-op complications that require recent inpatient management; patients who were required to stay in the hospital \>1 week post-op; revision surgery patients; heart failure patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Body Weight | Baseline and 6 month follow up | Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ways of Savoring Checklist (WOSC). | 6-month follow-up | Four questions from Bryant and Veroffs Ways of Savoring Checklist (WOSC) were used to assess momentary sensory-perceptual sharpening (ex 'I tried to intensify the moment by focusing on it') and intensifying positive emotional reactions to positive events as 'amplifying' savoring (ex. 'In the last week, I enjoyed the little things in life more fully'). The instrument uses a 5-point Likert scale (ranging from 0 = Strongly Disagree to 5 = Strongly Agree). Scale Range: 4-20 Higher scores on the WOSC indicate a stronger perceived ability to savor positive experiences. |
| Dietary Restraint | 6 month follow up | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 20 questions about restraint. Each item is scored either 0 or 1; therefore, the range is 0-20, with higher scores indicating greater levels of dietary restraint. |
| Dietary Disinhibition | 6 month follow-up | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 16 items about disinhibition. Each item is scored either 0 or 1; therefore, the range is 0-16, with higher levels indicating greater levels of dietary disinhibition. |
| Interoceptive Awareness | 6 month follow up | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a self-report instrument utilizing a 6-point Likert scale (ranging from 0 = Never to 5 = Always). Scale Range: 0-55 Higher scores on the MAIA indicate higher ability of interoceptive bodily awareness. |
| Hedonic Hunger | 6 months | Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 15 items about general levels of hunger. Each item is scored either 0 or 1; therefore, the range is 0-15, with higher scores indicating greater levels of hedonic hunger. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited via physician referral at the University of Utah Weight Management Program, electronic health record referrals, and general weight loss maintenance advertisement flyers posted throughout Salt Lake City, Utah. Recruitment explicitly stated the intervention being a mindfulness approach for promoting weight loss maintenance. Interested individuals were invited to complete an online screening form through REDCap.
Pre-assignment details
Seven participants were withdrawn before assignment: 2 ineligible, 2 scheduling conflicts, 1 COVID exposure, 1 family tragedy, 1 unknown reason.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention 8-week MORE intervention adapted for preventing weight regain
Mindfulness Orientated Recovery Enhancement: The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing. | 19 |
| Control Intervention 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program.
Control Intervention: The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention. | 22 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discovered not eligible - recent cancer diagnosis | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Scheduling Conflicts | 6 | 9 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Intervention | Total | Mindfulness Orientated Recovery Enhancement (MORE) Intervention |
|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 9.9 | 42.5 years STANDARD_DEVIATION 9.8 | 40.4 years STANDARD_DEVIATION 9.6 |
| Alcohol Use Disorders Identification Test (AUDIT) | 1.3 units on a scale STANDARD_DEVIATION 3.4 | 1.2 units on a scale STANDARD_DEVIATION 2.7 | 1.0 units on a scale STANDARD_DEVIATION 1.4 |
| Body Weight | 92.8 kilogram STANDARD_DEVIATION 26.1 | 92.7 kilogram STANDARD_DEVIATION 23.9 | 92.6 kilogram STANDARD_DEVIATION 21.8 |
| EATS-26 | 11.7 units on a scale STANDARD_DEVIATION 7.9 | 12.9 units on a scale STANDARD_DEVIATION 7.1 | 14.3 units on a scale STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 36 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PHQ-9 | 5.6 units on a scale STANDARD_DEVIATION 3.8 | 5.5 units on a scale STANDARD_DEVIATION 3.9 | 5.3 units on a scale STANDARD_DEVIATION 4.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 40 Participants | 18 Participants |
| Region of Enrollment United States | 22 participants | 41 participants | 19 participants |
| Sex: Female, Male Female | 20 Participants | 33 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 22 |
| other Total, other adverse events | 0 / 19 | 0 / 22 |
| serious Total, serious adverse events | 0 / 19 | 0 / 22 |
Outcome results
Primary
Changes in Body Weight
Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss.
Time frame: Baseline and 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Changes in Body Weight | 2.45 kilograms | Standard Deviation 1.02 |
| Control Intervention | Changes in Body Weight | -3.78 kilograms | Standard Deviation 1.2 |
p-value: <0.001Regression, Linear
Secondary
Dietary Disinhibition
Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 16 items about disinhibition. Each item is scored either 0 or 1; therefore, the range is 0-16, with higher levels indicating greater levels of dietary disinhibition.
Time frame: 6 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Dietary Disinhibition | 5.14 score on a scale | Standard Error 0.67 |
| Control Intervention | Dietary Disinhibition | 4.60 score on a scale | Standard Error 0.67 |
Secondary
Dietary Restraint
Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 20 questions about restraint. Each item is scored either 0 or 1; therefore, the range is 0-20, with higher scores indicating greater levels of dietary restraint.
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Dietary Restraint | 7.81 score on a scale | Standard Error 0.83 |
| Control Intervention | Dietary Restraint | 7.23 score on a scale | Standard Error 0.88 |
p-value: 0.62Regression, Linear
Secondary
Hedonic Hunger
Participants completed the Three-Factor Eating Questionnaire (TFEQ) in a fasted state to measure dietary restraint (conscious restriction of food intake to prevent weight gain or to promote weight loss), disinhibition (tendency to eat opportunistically), and hunger. This questionnaire consists of 15 items about general levels of hunger. Each item is scored either 0 or 1; therefore, the range is 0-15, with higher scores indicating greater levels of hedonic hunger.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Hedonic Hunger | 12.84 score on a scale | Standard Error 0.74 |
| Control Intervention | Hedonic Hunger | 14.61 score on a scale | Standard Error 0.82 |
p-value: 0.11Regression, Linear
Secondary
Interoceptive Awareness
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a self-report instrument utilizing a 6-point Likert scale (ranging from 0 = Never to 5 = Always). Scale Range: 0-55 Higher scores on the MAIA indicate higher ability of interoceptive bodily awareness.
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Interoceptive Awareness | 24.0 score on a scale | Standard Error 0.94 |
| Control Intervention | Interoceptive Awareness | 22.3 score on a scale | Standard Error 1.04 |
p-value: 0.21Regression, Linear
Secondary
Ways of Savoring Checklist (WOSC).
Four questions from Bryant and Veroffs Ways of Savoring Checklist (WOSC) were used to assess momentary sensory-perceptual sharpening (ex 'I tried to intensify the moment by focusing on it') and intensifying positive emotional reactions to positive events as 'amplifying' savoring (ex. 'In the last week, I enjoyed the little things in life more fully'). The instrument uses a 5-point Likert scale (ranging from 0 = Strongly Disagree to 5 = Strongly Agree). Scale Range: 4-20 Higher scores on the WOSC indicate a stronger perceived ability to savor positive experiences.
Time frame: 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Orientated Recovery Enhancement (MORE) Intervention | Ways of Savoring Checklist (WOSC). | 16.2 score on a scale | Standard Error 0.51 |
| Control Intervention | Ways of Savoring Checklist (WOSC). | 17.1 score on a scale | Standard Error 0.55 |
p-value: 0.22Regression, Linear