Trial Outcomes & Findings for Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss (NCT NCT04337619)
NCT ID: NCT04337619
Last Updated: 2026-03-11
Results Overview
Measured at home using a standardized weighing procedure. Participants will be weighed in lightweight clothes without shoes using a standardized bluetooth scale accurate to 0.1 kg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
276 participants
Primary outcome timeframe
Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).
Results posted on
2026-03-11
Participant Flow
Participant milestones
| Measure |
Standard Behavioral Weight Loss Treatment
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
32
|
35
|
36
|
34
|
38
|
32
|
|
Overall Study
COMPLETED
|
28
|
31
|
23
|
29
|
29
|
27
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
9
|
6
|
7
|
7
|
14
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
Baseline characteristics by cohort
| Measure |
Standard Behavioral Weight Loss Treatment
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
n=36 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
n=38 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=359 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=56 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=9 Participants
|
32 Participants
n=9 Participants
|
22 Participants
n=18 Participants
|
33 Participants
n=15 Participants
|
32 Participants
n=60 Participants
|
30 Participants
n=359 Participants
|
35 Participants
n=21 Participants
|
32 Participants
n=4 Participants
|
248 Participants
n=56 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
10 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=60 Participants
|
4 Participants
n=359 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
28 Participants
n=56 Participants
|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 9.96 • n=9 Participants
|
51.5 years
STANDARD_DEVIATION 10.6 • n=9 Participants
|
53.8 years
STANDARD_DEVIATION 14.3 • n=18 Participants
|
51.1 years
STANDARD_DEVIATION 11.7 • n=15 Participants
|
52.7 years
STANDARD_DEVIATION 10.0 • n=60 Participants
|
55.4 years
STANDARD_DEVIATION 8.85 • n=359 Participants
|
49.6 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
49.5 years
STANDARD_DEVIATION 9.27 • n=4 Participants
|
51.8 years
STANDARD_DEVIATION 10.92 • n=56 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=9 Participants
|
27 Participants
n=9 Participants
|
27 Participants
n=18 Participants
|
28 Participants
n=15 Participants
|
36 Participants
n=60 Participants
|
30 Participants
n=359 Participants
|
34 Participants
n=21 Participants
|
27 Participants
n=4 Participants
|
238 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
5 Participants
n=18 Participants
|
7 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
4 Participants
n=359 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=4 Participants
|
38 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=359 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=359 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=359 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
11 Participants
n=9 Participants
|
6 Participants
n=18 Participants
|
7 Participants
n=15 Participants
|
7 Participants
n=60 Participants
|
8 Participants
n=359 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=4 Participants
|
56 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=9 Participants
|
22 Participants
n=9 Participants
|
23 Participants
n=18 Participants
|
26 Participants
n=15 Participants
|
26 Participants
n=60 Participants
|
26 Participants
n=359 Participants
|
30 Participants
n=21 Participants
|
23 Participants
n=4 Participants
|
204 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=359 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=359 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=56 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=9 Participants
|
35 participants
n=9 Participants
|
32 participants
n=18 Participants
|
35 participants
n=15 Participants
|
36 participants
n=60 Participants
|
34 participants
n=359 Participants
|
38 participants
n=21 Participants
|
32 participants
n=4 Participants
|
276 participants
n=56 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).Measured at home using a standardized weighing procedure. Participants will be weighed in lightweight clothes without shoes using a standardized bluetooth scale accurate to 0.1 kg.
Outcome measures
| Measure |
Behavioral + Values
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
n=36 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Standard Behavioral Weight Loss Treatment
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
n=38 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
|---|---|---|---|---|---|---|---|---|
|
Weight Change
6-month follow-up
|
7.07 percentage of weight change
Standard Deviation 11.14
|
6.83 percentage of weight change
Standard Deviation 8.81
|
4.62 percentage of weight change
Standard Deviation 8.28
|
7.65 percentage of weight change
Standard Deviation 8.74
|
7.86 percentage of weight change
Standard Deviation 7.65
|
7.04 percentage of weight change
Standard Deviation 9.20
|
4.22 percentage of weight change
Standard Deviation 7.96
|
3.76 percentage of weight change
Standard Deviation 7.45
|
|
Weight Change
12-month follow-up
|
5.91 percentage of weight change
Standard Deviation 11.74
|
5.56 percentage of weight change
Standard Deviation 7.95
|
3.28 percentage of weight change
Standard Deviation 8.66
|
6.05 percentage of weight change
Standard Deviation 8.78
|
6.85 percentage of weight change
Standard Deviation 7.67
|
5.33 percentage of weight change
Standard Deviation 9.30
|
3.47 percentage of weight change
Standard Deviation 7.11
|
3.72 percentage of weight change
Standard Deviation 8.19
|
|
Weight Change
24-month follow-up
|
4.47 percentage of weight change
Standard Deviation 10.37
|
5.72 percentage of weight change
Standard Deviation 8.02
|
2.62 percentage of weight change
Standard Deviation 8.43
|
6.48 percentage of weight change
Standard Deviation 11.92
|
5.48 percentage of weight change
Standard Deviation 7.58
|
3.78 percentage of weight change
Standard Deviation 9.19
|
1.87 percentage of weight change
Standard Deviation 8.52
|
1.81 percentage of weight change
Standard Deviation 8.14
|
|
Weight Change
post-treatment
|
8.66 percentage of weight change
Standard Deviation 10.69
|
9.26 percentage of weight change
Standard Deviation 8.52
|
7.47 percentage of weight change
Standard Deviation 8.05
|
9.32 percentage of weight change
Standard Deviation 9.73
|
9.32 percentage of weight change
Standard Deviation 7.88
|
8.21 percentage of weight change
Standard Deviation 9.14
|
6.46 percentage of weight change
Standard Deviation 7.87
|
6.06 percentage of weight change
Standard Deviation 7.83
|
|
Weight Change
mid-treatment
|
8.19 percentage of weight change
Standard Deviation 6.54
|
9.11 percentage of weight change
Standard Deviation 6.53
|
7.93 percentage of weight change
Standard Deviation 6.94
|
9.17 percentage of weight change
Standard Deviation 7.80
|
9.36 percentage of weight change
Standard Deviation 5.34
|
7.71 percentage of weight change
Standard Deviation 7.22
|
7.33 percentage of weight change
Standard Deviation 6.88
|
7.66 percentage of weight change
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months).Population: As acknowledged in the limitation section, average daily calorie intake was not included in the imputation model and later analyses as a secondary outcome because this measure expected to be strongly biased by participants' adherence to food tracking. The descriptive statistics (e.g., mean, standard deviation) reported in the table below were computed using available data with missing data points excluded.
Dietary intake was recorded on the popular mobile application MyFitnessPal.
Outcome measures
| Measure |
Behavioral + Values
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
n=36 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Standard Behavioral Weight Loss Treatment
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
n=38 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
|---|---|---|---|---|---|---|---|---|
|
Dietary Intake
baseline
|
1571.25 kcal/day
Standard Deviation 260.25
|
1633.52 kcal/day
Standard Deviation 344.76
|
1711.33 kcal/day
Standard Deviation 449.91
|
1437.44 kcal/day
Standard Deviation 505.88
|
1260.20 kcal/day
Standard Deviation NA
only one participant reported dietary intake in this condition at baseline and thus cannot compute standard deviation
|
1664.37 kcal/day
Standard Deviation 460.12
|
1711.65 kcal/day
Standard Deviation 348.94
|
1905.64 kcal/day
Standard Deviation 511.92
|
|
Dietary Intake
6 months
|
1338.89 kcal/day
Standard Deviation 231.28
|
1460.61 kcal/day
Standard Deviation 247.19
|
1448.99 kcal/day
Standard Deviation 300.43
|
1336.43 kcal/day
Standard Deviation 259.24
|
1467.43 kcal/day
Standard Deviation 324.68
|
1350.94 kcal/day
Standard Deviation 217.21
|
1378.07 kcal/day
Standard Deviation 295.78
|
1567.15 kcal/day
Standard Deviation 345.08
|
|
Dietary Intake
12 months
|
1426.72 kcal/day
Standard Deviation 298.10
|
1460.44 kcal/day
Standard Deviation 238.06
|
1543.01 kcal/day
Standard Deviation 352.15
|
1420.34 kcal/day
Standard Deviation 334.61
|
1493.16 kcal/day
Standard Deviation 376.70
|
1469.33 kcal/day
Standard Deviation 311.68
|
1419.38 kcal/day
Standard Deviation 365.44
|
1567.04 kcal/day
Standard Deviation 368.50
|
SECONDARY outcome
Timeframe: Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).Measured in minutes per week of moderate-to-vigorous physical activity (MVPA) using one wrist-worn activity tracker including Fitbit Charge 2, 3, 4, and 5.
Outcome measures
| Measure |
Behavioral + Values
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
n=36 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Standard Behavioral Weight Loss Treatment
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
n=38 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
|---|---|---|---|---|---|---|---|---|
|
Physical Activity
6-month follow-up
|
231.61 minutes per week
Standard Deviation 184.11
|
167.83 minutes per week
Standard Deviation 156.03
|
208.43 minutes per week
Standard Deviation 160.38
|
295.53 minutes per week
Standard Deviation 325.74
|
178.70 minutes per week
Standard Deviation 179.92
|
243.15 minutes per week
Standard Deviation 219.04
|
180.12 minutes per week
Standard Deviation 149.02
|
236.66 minutes per week
Standard Deviation 184.29
|
|
Physical Activity
12-month follow-up
|
214.28 minutes per week
Standard Deviation 189.47
|
138.92 minutes per week
Standard Deviation 124.77
|
167.22 minutes per week
Standard Deviation 136.10
|
203.15 minutes per week
Standard Deviation 241.71
|
180.81 minutes per week
Standard Deviation 170.42
|
243.97 minutes per week
Standard Deviation 218.37
|
160.14 minutes per week
Standard Deviation 173.05
|
198.19 minutes per week
Standard Deviation 141.79
|
|
Physical Activity
24-month follow-up
|
228.29 minutes per week
Standard Deviation 202.07
|
168.15 minutes per week
Standard Deviation 154.65
|
192.11 minutes per week
Standard Deviation 200.67
|
225.87 minutes per week
Standard Deviation 244.77
|
139.76 minutes per week
Standard Deviation 157.12
|
246.84 minutes per week
Standard Deviation 213.06
|
173.73 minutes per week
Standard Deviation 170.26
|
208.37 minutes per week
Standard Deviation 155.20
|
|
Physical Activity
baseline
|
231.49 minutes per week
Standard Deviation 145.70
|
173.01 minutes per week
Standard Deviation 194.31
|
230.64 minutes per week
Standard Deviation 164.39
|
222.57 minutes per week
Standard Deviation 228.59
|
195.98 minutes per week
Standard Deviation 172.37
|
222.94 minutes per week
Standard Deviation 234.38
|
206.24 minutes per week
Standard Deviation 175.86
|
207.66 minutes per week
Standard Deviation 177.83
|
|
Physical Activity
mid-treatment
|
244.61 minutes per week
Standard Deviation 157.59
|
195.04 minutes per week
Standard Deviation 173.92
|
231.60 minutes per week
Standard Deviation 171.10
|
296.40 minutes per week
Standard Deviation 251.77
|
200.54 minutes per week
Standard Deviation 157.48
|
248.14 minutes per week
Standard Deviation 181.86
|
201.98 minutes per week
Standard Deviation 151.01
|
275.13 minutes per week
Standard Deviation 232.00
|
|
Physical Activity
post-treatment
|
215.64 minutes per week
Standard Deviation 175.72
|
150.49 minutes per week
Standard Deviation 122.28
|
241.44 minutes per week
Standard Deviation 174.75
|
277.56 minutes per week
Standard Deviation 216.10
|
221.43 minutes per week
Standard Deviation 210.28
|
228.93 minutes per week
Standard Deviation 175.65
|
189.64 minutes per week
Standard Deviation 141.79
|
230.93 minutes per week
Standard Deviation 147.60
|
SECONDARY outcome
Timeframe: Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).Measured using the Quality of Life Inventory (QOLI). The min and max values are 1 and 18. Higher scores mean a better outcome.
Outcome measures
| Measure |
Behavioral + Values
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
n=36 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Standard Behavioral Weight Loss Treatment
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
n=35 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
n=34 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
n=38 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
n=32 Participants
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
|---|---|---|---|---|---|---|---|---|
|
Quality of Life Score
baseline
|
11.01 score on a scale
Standard Deviation 2.22
|
10.50 score on a scale
Standard Deviation 2.18
|
10.85 score on a scale
Standard Deviation 2.24
|
10.36 score on a scale
Standard Deviation 2.55
|
10.58 score on a scale
Standard Deviation 2.91
|
10.52 score on a scale
Standard Deviation 2.39
|
10.79 score on a scale
Standard Deviation 2.57
|
9.93 score on a scale
Standard Deviation 1.96
|
|
Quality of Life Score
mid-treatment
|
10.99 score on a scale
Standard Deviation 2.89
|
10.84 score on a scale
Standard Deviation 2.74
|
10.85 score on a scale
Standard Deviation 2.77
|
10.78 score on a scale
Standard Deviation 2.31
|
10.94 score on a scale
Standard Deviation 2.88
|
10.96 score on a scale
Standard Deviation 2.54
|
10.58 score on a scale
Standard Deviation 2.75
|
10.51 score on a scale
Standard Deviation 2.20
|
|
Quality of Life Score
post-treatment
|
10.63 score on a scale
Standard Deviation 2.71
|
11.28 score on a scale
Standard Deviation 2.74
|
10.71 score on a scale
Standard Deviation 2.81
|
10.34 score on a scale
Standard Deviation 2.40
|
10.82 score on a scale
Standard Deviation 2.96
|
11.09 score on a scale
Standard Deviation 2.59
|
10.57 score on a scale
Standard Deviation 2.72
|
10.59 score on a scale
Standard Deviation 2.16
|
|
Quality of Life Score
6-month follow-up
|
10.57 score on a scale
Standard Deviation 2.98
|
10.52 score on a scale
Standard Deviation 2.57
|
10.43 score on a scale
Standard Deviation 2.76
|
10.51 score on a scale
Standard Deviation 2.90
|
10.35 score on a scale
Standard Deviation 3.43
|
10.64 score on a scale
Standard Deviation 2.45
|
9.91 score on a scale
Standard Deviation 2.65
|
9.85 score on a scale
Standard Deviation 2.65
|
|
Quality of Life Score
12-month follow-up
|
10.55 score on a scale
Standard Deviation 2.96
|
10.81 score on a scale
Standard Deviation 2.91
|
10.82 score on a scale
Standard Deviation 2.60
|
10.41 score on a scale
Standard Deviation 2.36
|
10.68 score on a scale
Standard Deviation 3.00
|
10.63 score on a scale
Standard Deviation 2.86
|
9.69 score on a scale
Standard Deviation 3.00
|
10.13 score on a scale
Standard Deviation 2.05
|
|
Quality of Life Score
24-month follow-up
|
10.63 score on a scale
Standard Deviation 3.24
|
10.60 score on a scale
Standard Deviation 2.86
|
10.80 score on a scale
Standard Deviation 2.75
|
10.58 score on a scale
Standard Deviation 2.70
|
10.85 score on a scale
Standard Deviation 3.30
|
10.17 score on a scale
Standard Deviation 3.20
|
10.07 score on a scale
Standard Deviation 3.00
|
10.37 score on a scale
Standard Deviation 2.37
|
Adverse Events
Standard Behavioral Weight Loss Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Behavioral + Willingness
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Behavioral + Values
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral + Mindful Awareness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral + Willingness + Values
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Behavioral + Willingness + Awareness
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Behavioral + Values + Awareness
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Behavioral + Willingness + Values + Awareness
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Behavioral Weight Loss Treatment
n=34 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
n=35 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values
n=32 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
n=35 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
n=36 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
n=34 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
n=38 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
n=32 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
ER visit for SVT
|
0.00%
0/34 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/36 • up to 36 months
|
2.9%
1/34 • Number of events 1 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
|
Surgical and medical procedures
Knee replacement with hospitalization
|
0.00%
0/34 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
2.8%
1/36 • Number of events 1 • up to 36 months
|
0.00%
0/34 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
Other adverse events
| Measure |
Standard Behavioral Weight Loss Treatment
n=34 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Behavioral + Willingness
n=35 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values
n=32 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Mindful Awareness
n=35 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values
n=36 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Awareness
n=34 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Values + Awareness
n=38 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Behavioral + Willingness + Values + Awareness
n=32 participants at risk
Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered)
Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
surgery and chemotherapy
|
0.00%
0/34 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
2.8%
1/36 • Number of events 1 • up to 36 months
|
0.00%
0/34 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
|
Surgical and medical procedures
Knee surgery
|
0.00%
0/34 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
2.8%
1/36 • Number of events 1 • up to 36 months
|
0.00%
0/34 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
|
Surgical and medical procedures
Foot surgery
|
0.00%
0/34 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/36 • up to 36 months
|
2.9%
1/34 • Number of events 1 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
|
Surgical and medical procedures
rectocele surgery
|
0.00%
0/34 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/36 • up to 36 months
|
0.00%
0/34 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
3.1%
1/32 • Number of events 1 • up to 36 months
|
|
Injury, poisoning and procedural complications
Foot Injury
|
0.00%
0/34 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/36 • up to 36 months
|
0.00%
0/34 • up to 36 months
|
2.6%
1/38 • Number of events 1 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
|
Injury, poisoning and procedural complications
shoulder, neck, leg injury
|
0.00%
0/34 • up to 36 months
|
2.9%
1/35 • Number of events 2 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/36 • up to 36 months
|
0.00%
0/34 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
|
Surgical and medical procedures
tearing their rotator cuff
|
2.9%
1/34 • Number of events 1 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
0.00%
0/35 • up to 36 months
|
0.00%
0/36 • up to 36 months
|
0.00%
0/34 • up to 36 months
|
0.00%
0/38 • up to 36 months
|
0.00%
0/32 • up to 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place