Trial Outcomes & Findings for Episodic Future Thinking and Weight-Loss (NCT NCT03731325)

NCT ID: NCT03731325

Last Updated: 2024-10-22

Results Overview

Height (cm) and weight (lbs) will be assessed to calculate BMI (kg/m\^2) for parents. Change will be assessed at baseline, week 8, 11 and 15 from baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Change from Baseline BMI at week 8, 11 and 15

Results posted on

2024-10-22

Participant Flow

Particpants were parent-child dyads, so each unit dyad consists of 1 parent and 1 child, e.g. 4 dyads enrolled in Episodic future thinking group 7-week baseline and 3 dyads enrolled in episodic future thinking group 10-week baseline

Participant milestones

Participant milestones
Measure
Episodic Future Thinking Group 7-week Baseline
The experimental group will receive the Episodic Future Thinking (EFT) intervention after a 7-week baseline. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Episodic Future Thinking Group 10-week Baseline
The experimental group will receive the Episodic Future Thinking (EFT) intervention after a 10-week baseline. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Overall Study
STARTED
4
3
Overall Study
COMPLETED
4
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parent information n = 7

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Episodic Future Thinking Group 7-week Baseline
n=4 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after a 7-week baseline. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Episodic Future Thinking Group 10-week Baseline
n=3 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after a 10-week baseline. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Total
n=7 Participants
Total of all reporting groups
Age, Continuous
10.5 years
STANDARD_DEVIATION 0.6 • n=5 Participants • child information n = 7
10.7 years
STANDARD_DEVIATION 0.6 • n=7 Participants • child information n = 7
10.6 years
STANDARD_DEVIATION 0.5 • n=5 Participants • child information n = 7
Sex: Female, Male
Female
2 Participants
n=5 Participants • child information n = 7
2 Participants
n=7 Participants • child information n = 7
4 Participants
n=5 Participants • child information n = 7
Sex: Female, Male
Male
2 Participants
n=5 Participants • child information n = 7
1 Participants
n=7 Participants • child information n = 7
3 Participants
n=5 Participants • child information n = 7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants • child information n = 7
0 Participants
n=7 Participants • child information n = 7
1 Participants
n=5 Participants • child information n = 7
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=5 Participants • child information n = 7
3 Participants
n=7 Participants • child information n = 7
6 Participants
n=5 Participants • child information n = 7
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants • child information n = 7
0 Participants
n=7 Participants • child information n = 7
0 Participants
n=5 Participants • child information n = 7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants • child information n = 7
0 Participants
n=7 Participants • child information n = 7
0 Participants
n=5 Participants • child information n = 7
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants • child information n = 7
0 Participants
n=7 Participants • child information n = 7
0 Participants
n=5 Participants • child information n = 7
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants • child information n = 7
0 Participants
n=7 Participants • child information n = 7
0 Participants
n=5 Participants • child information n = 7
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants • child information n = 7
1 Participants
n=7 Participants • child information n = 7
2 Participants
n=5 Participants • child information n = 7
Race (NIH/OMB)
White
3 Participants
n=5 Participants • child information n = 7
2 Participants
n=7 Participants • child information n = 7
5 Participants
n=5 Participants • child information n = 7
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants • child information n = 7
0 Participants
n=7 Participants • child information n = 7
0 Participants
n=5 Participants • child information n = 7
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants • child information n = 7
0 Participants
n=7 Participants • child information n = 7
0 Participants
n=5 Participants • child information n = 7
Region of Enrollment
United States
4 dyads
n=5 Participants
3 dyads
n=7 Participants
7 dyads
n=5 Participants
Parent Body Mass Index (BMI)
32.7 kg/m^2
STANDARD_DEVIATION 16.8 • n=5 Participants • Parent BMI is reported (n = 7)
36.9 kg/m^2
STANDARD_DEVIATION 7.9 • n=7 Participants • Parent BMI is reported (n = 7)
34.5 kg/m^2
STANDARD_DEVIATION 12.9 • n=5 Participants • Parent BMI is reported (n = 7)
Child BMI percentile
95.5 standardized percentile
STANDARD_DEVIATION 4.7 • n=5 Participants • Child (n = 7) measured BMI percentile
95.7 standardized percentile
STANDARD_DEVIATION 3.1 • n=7 Participants • Child (n = 7) measured BMI percentile
95.6 standardized percentile
STANDARD_DEVIATION 3.8 • n=5 Participants • Child (n = 7) measured BMI percentile

PRIMARY outcome

Timeframe: Change from Baseline BMI at week 8, 11 and 15

Population: Parents (n = 7) will be analyzed for change in BMI from baseline

Height (cm) and weight (lbs) will be assessed to calculate BMI (kg/m\^2) for parents. Change will be assessed at baseline, week 8, 11 and 15 from baseline.

Outcome measures

Outcome measures
Measure
Episodic Future Thinking Group 7-week Baseline
n=4 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 7-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Episodic Future Thinking 10-week Baseline
n=3 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 10-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15
Parent Baseline BMI
32.7 kg/m^2
Standard Deviation 16.8
36.9 kg/m^2
Standard Deviation 7.9
Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15
Change in parent BMI from baseline to week 8
-1.3 kg/m^2
Standard Deviation 1.2
-1.9 kg/m^2
Standard Deviation 1.0
Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15
Change in Parent BMI from baseline to week 11
-1.7 kg/m^2
Standard Deviation 1.2
-2.2 kg/m^2
Standard Deviation 0.9
Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15
Change in parent BMI from baseline to week 15
-1.9 kg/m^2
Standard Deviation 1.6
-2.6 kg/m^2
Standard Deviation 0.9

PRIMARY outcome

Timeframe: Change from Baseline weight at week 8, 11 and 15

Weight was measured in lbs

Outcome measures

Outcome measures
Measure
Episodic Future Thinking Group 7-week Baseline
n=4 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 7-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Episodic Future Thinking 10-week Baseline
n=3 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 10-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Change in Weight for Parents From Baseline at Weeks 8, 11 and 15
Change in weight (lbs) from 0 to 8 weeks
-5.8 pounds
Standard Deviation 2.6
-7.2 pounds
Standard Deviation 3.0
Change in Weight for Parents From Baseline at Weeks 8, 11 and 15
Change in weight (lbs) from 0 to 11 weeks
-8.5 pounds
Standard Deviation 2.4
-9.1 pounds
Standard Deviation 2.1
Change in Weight for Parents From Baseline at Weeks 8, 11 and 15
Change in weight (lbs) from 0 to 15 weeks
-9.6 pounds
Standard Deviation 5.1
-11.7 pounds
Standard Deviation 2.7

PRIMARY outcome

Timeframe: Baseline, 8, 11 and 15 weeks

Population: Children (n = 7) analysis

Change in BMI percentile for children from 0, 8, 11 and 15 weeks

Outcome measures

Outcome measures
Measure
Episodic Future Thinking Group 7-week Baseline
n=4 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 7-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Episodic Future Thinking 10-week Baseline
n=3 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 10-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Change in BMI Percentile for Children
Baseline Child BMI percentile
95.5 Standardized percentile
Standard Deviation 4.8
95.7 Standardized percentile
Standard Deviation 3.1
Change in BMI Percentile for Children
Change in child BMI percentile from baseline to 8 weeks
-1.8 Standardized percentile
Standard Deviation 2.8
-4.3 Standardized percentile
Standard Deviation 5.9
Change in BMI Percentile for Children
change in child BMI percentile from 0 to 11 weeks
-1.7 Standardized percentile
Standard Deviation 2.9
-4.9 Standardized percentile
Standard Deviation 6.4
Change in BMI Percentile for Children
Change in child BMI percentile from baseline to 15 weeks
-1.3 Standardized percentile
Standard Deviation 3.9
-4.3 Standardized percentile
Standard Deviation 4.5

PRIMARY outcome

Timeframe: Change from Baseline weight at week 8, 11 and 15

Population: child

Weight was measured in lbs and examined as change from baseline in lbs at week 8, 11 and 15

Outcome measures

Outcome measures
Measure
Episodic Future Thinking Group 7-week Baseline
n=4 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 7-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Episodic Future Thinking 10-week Baseline
n=3 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 10-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Change in Weight for Children From Baseline at Weeks 8, 11 and 15
Change in weight (lbs) from 0 to 8 weeks
-0.78 pounds
Standard Deviation 2.61
-2.50 pounds
Standard Deviation 4.30
Change in Weight for Children From Baseline at Weeks 8, 11 and 15
Change in weight (lbs) from 0 to 11 weeks
-0.73 pounds
Standard Deviation 3.20
-1.73 pounds
Standard Deviation 6.23
Change in Weight for Children From Baseline at Weeks 8, 11 and 15
Change in weight (lbs) from 0 to 15 weeks
-0.08 pounds
Standard Deviation 4.41
-1.77 pounds
Standard Deviation 4.85

SECONDARY outcome

Timeframe: Baseline, 10 weeks, 15 weeks

Population: n = 7 children

Delay Discounting will be measured using monetary Delay Discounting tasks with $100 as the delayed reward. Delay discounting is assessed using Area Under the Curve (AUC), or time\*indifference point/delay. AUC for delay discounting included time (x-axis) and indifference point (y-axis), or the amount of money at which the immediate and delayed options are approximately equal. Indifference points are a proportion of the max amount (range 0 - 100) and delays are calculated as proportion of max delay. AUC adds the calculated areas for each timepoint from the previous timepoint. AUC ranges from 0 (most impulsive, did not choose delay) to 100 (least impulsive, always chose delay). As this is a measure that is standardized, units are proportion of maximum delayed reward x proportion of maximum delay.

Outcome measures

Outcome measures
Measure
Episodic Future Thinking Group 7-week Baseline
n=4 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 7-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Episodic Future Thinking 10-week Baseline
n=3 Participants
The experimental group will receive the Episodic Future Thinking (EFT) intervention after 10-weeks. EFT teaches individuals to pre-experience events, or think prospectively, about future events as if they were happening now \[Atance\]. Episodic Future Thinking Group: Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create "cues." Cues are descriptions of future events the participant can vividly imagine as happening right now. Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision.
Delay Discounting for Children
Baseline Area Under the curve
0.28 proportion max reward x proportion delay
Standard Deviation 0.13
0.22 proportion max reward x proportion delay
Standard Deviation 0.06
Delay Discounting for Children
Week 10 Area under the curve
0.34 proportion max reward x proportion delay
Standard Deviation 0.17
0.35 proportion max reward x proportion delay
Standard Deviation 0.15
Delay Discounting for Children
Week 15 Area under the curve
0.36 proportion max reward x proportion delay
Standard Deviation 0.12
0.35 proportion max reward x proportion delay
Standard Deviation 0.14

Adverse Events

Episodic Future Thinking Group - 7 Week Parents

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Episodic Future Thinking Group 7-week Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Episodic Future Thinking Group - 10 Week Parents

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Episodic Future Thinking Group - 10 Week Children

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

Tina Day

Washington University in St. Louis

Phone: 314-286-0079

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place