Trial Outcomes & Findings for Eating Mindfully to Prevent Weight Regain (NCT NCT04847843)

Last Updated: 2025-11-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

Baseline and 6 month follow up

Results posted on

2025-11-25

Participant Flow

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.

Seven participants were withdrawn before assignment: 2 ineligible, 2 scheduling conflicts, 1 COVID exposure, 1 family tragedy, 1 unknown reason.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19	22
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	8	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Scheduling Conflicts	6	9
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	1	1
Overall Study Pregnancy	0	2
Overall Study Discovered not eligible - recent cancer diagnosis	0	1

Baseline Characteristics

Eating Mindfully to Prevent Weight Regain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Orientated Recovery Enhancement (MORE) Intervention n=19 Participants 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.	Control Intervention n=22 Participants 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.	Total n=41 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 9.6 • n=45 Participants	44.3 years STANDARD_DEVIATION 9.9 • n=12929 Participants	42.5 years STANDARD_DEVIATION 9.8 • n=6349 Participants
Sex: Female, Male Female	13 Participants n=45 Participants	20 Participants n=12929 Participants	33 Participants n=6349 Participants
Sex: Female, Male Male	6 Participants n=45 Participants	2 Participants n=12929 Participants	8 Participants n=6349 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=45 Participants	1 Participants n=12929 Participants	5 Participants n=6349 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=45 Participants	21 Participants n=12929 Participants	36 Participants n=6349 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Asian	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=45 Participants	0 Participants n=12929 Participants	1 Participants n=6349 Participants
Race (NIH/OMB) Black or African American	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) White	18 Participants n=45 Participants	22 Participants n=12929 Participants	40 Participants n=6349 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Region of Enrollment United States	19 participants n=45 Participants	22 participants n=12929 Participants	41 participants n=6349 Participants
Body Weight	92.6 kilogram STANDARD_DEVIATION 21.8 • n=45 Participants	92.8 kilogram STANDARD_DEVIATION 26.1 • n=12929 Participants	92.7 kilogram STANDARD_DEVIATION 23.9 • n=6349 Participants
EATS-26	14.3 units on a scale STANDARD_DEVIATION 5.9 • n=45 Participants	11.7 units on a scale STANDARD_DEVIATION 7.9 • n=12929 Participants	12.9 units on a scale STANDARD_DEVIATION 7.1 • n=6349 Participants
Alcohol Use Disorders Identification Test (AUDIT)	1.0 units on a scale STANDARD_DEVIATION 1.4 • n=45 Participants	1.3 units on a scale STANDARD_DEVIATION 3.4 • n=12929 Participants	1.2 units on a scale STANDARD_DEVIATION 2.7 • n=6349 Participants
PHQ-9	5.3 units on a scale STANDARD_DEVIATION 4.1 • n=45 Participants	5.6 units on a scale STANDARD_DEVIATION 3.8 • n=12929 Participants	5.5 units on a scale STANDARD_DEVIATION 3.9 • n=6349 Participants

PRIMARY outcome

Timeframe: Baseline and 6 month follow up

Outcome measures

Outcome measures
Measure	Control Intervention n=9 Participants 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.	Mindfulness Orientated Recovery Enhancement (MORE) Intervention n=11 Participants 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.
Changes in Body Weight	-3.78 kilograms Standard Deviation 1.2	2.45 kilograms Standard Deviation 1.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Intervention n=9 Participants 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.	Mindfulness Orientated Recovery Enhancement (MORE) Intervention n=11 Participants 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.
Ways of Savoring Checklist (WOSC).	17.1 score on a scale Standard Error 0.55	16.2 score on a scale Standard Error 0.51

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Intervention n=9 Participants 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.	Mindfulness Orientated Recovery Enhancement (MORE) Intervention n=11 Participants 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.
Dietary Restraint	7.23 score on a scale Standard Error 0.88	7.81 score on a scale Standard Error 0.83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Intervention n=9 Participants 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.	Mindfulness Orientated Recovery Enhancement (MORE) Intervention n=11 Participants 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.
Dietary Disinhibition	4.60 score on a scale Standard Error 0.67	5.14 score on a scale Standard Error 0.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Intervention n=9 Participants 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.	Mindfulness Orientated Recovery Enhancement (MORE) Intervention n=11 Participants 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.
Interoceptive Awareness	22.3 score on a scale Standard Error 1.04	24.0 score on a scale Standard Error 0.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Intervention n=9 Participants 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.	Mindfulness Orientated Recovery Enhancement (MORE) Intervention n=11 Participants 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.
Hedonic Hunger	14.61 score on a scale Standard Error 0.82	12.84 score on a scale Standard Error 0.74

Adverse Events

Mindfulness Orientated Recovery Enhancement (MORE) Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tanya Halliday, PhD, RD

University of Utah

Phone: 801-213-1364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place