Trial Outcomes & Findings for Craving and Lifestyle Management Through Mindfulness Study (NCT NCT01250509)

Results Overview

Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Change from Baseline in Abdominal Fat (baseline and 4 months)

Results posted on

2013-02-18

Participant Flow

Female participants were recruited through media outlets and flyers posted in the San Francisco Bay Area. Three hundred twenty-two potential participants were screened for eligibility from November 2006 to March 2007.

Fifty-three met eligibility criteria and chose to enroll, and 47 went on to the randomization stage. Before randomization, 5 participants dropped due to time constaints and 1 dropped due to illness.

Participant milestones

Participant milestones
Measure	CALMM Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.	Waitlist Control Participants were waitlisted for the intervention during the experimental phase.
Overall Study STARTED	24	23
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CALMM Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.	Waitlist Control Participants were waitlisted for the intervention during the experimental phase.
Overall Study Lost to Follow-up	5	2

Baseline Characteristics

Craving and Lifestyle Management Through Mindfulness Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CALMM n=24 Participants Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.	Waitlist Control n=23 Participants Participants were waitlisted for the intervention during the experimental phase.	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	40.4 years STANDARD_DEVIATION 8.0 • n=5 Participants	41.4 years STANDARD_DEVIATION 6.7 • n=7 Participants	40.9 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	23 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline in Abdominal Fat (baseline and 4 months)

Population: Intent-to-treat analyses were conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.

Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.

Outcome measures

Outcome measures
Measure	CALMM n=24 Participants	Waitlist n=23 Participants
Change in Abdominal Fat	68.2 grams Standard Deviation 318.9	50.0 grams Standard Deviation 305.4

SECONDARY outcome

Timeframe: Change in Weight (baseline and 4 months)

Population: Intention to treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.

Outcome measures

Outcome measures
Measure	CALMM n=24 Participants	Waitlist n=23 Participants
Weight	-0.03 kg Standard Deviation 2.7	0.38 kg Standard Deviation 1.9

SECONDARY outcome

Timeframe: Change from Baseline in Telomerase Activity at 4 months

Population: Intention-to-treat analysis was conducted.

Cryopreserved peripheral blood nuclear cells (PBMCs) were thawed and live cells counted using a hemocytometer by the Trypan blue exclusion method. For each sample, an extract of 5000 cells per microliter was made and two concentrations, corresponding to 5000 and 10,000 cells, were assayed for each sample to ensure the assay was in the linear range. Telomerase activity was assayed by the Telomerase Repeat Amplification Protocol (TRAP) using a commercial kit (TRAPeze, Telomerase Detection kit, Upstate/ CHEMICON, Temecula, CA). Baseline and post-intervention samples for the same participant were assayed in the same batch and run on the same gel to eliminate any differences caused by reaction or procedural batch-to-batch variations. Technicians were blind to group assignment. Telomerase activity is defined as 1 unit = the amount of product from one 293T cell/10,000 PBMCs, and was quantified using the software ImageQuant 5.2 (GE Healthcare, Piscataway, NJ).

Outcome measures

Outcome measures
Measure	CALMM n=19 Participants	Waitlist n=18 Participants
Telomerase Activity	0.24 Standard arbitrary units, see above Standard Deviation 0.5	0.15 Standard arbitrary units, see above Standard Deviation 0.3

SECONDARY outcome

Timeframe: Change from Baseline in Psychological Stress

Population: An intention-to-treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.

The 10-item Perceived Stress Scale was used to evaluate perception of stressful events over the past month by using a 5-point Likert scale (0 = never to 4 = very often) (Cohen et al., 1983). The mean of the ten items was used in analysis. Higher scores indicate greater perceived stress.

Outcome measures

Outcome measures
Measure	CALMM n=24 Participants	Waitlist n=23 Participants
Change in Psychological Stress (Baseline and 4 Months)	-0.20 units on a scale Standard Deviation 0.5	0.03 units on a scale Standard Deviation 0.6

Adverse Events

CALMM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control

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

Jennifer Daubenmier, PhD

University of California, San Francisco

Phone: 415-514-8601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place