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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD080292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Washington University School of Medicine | OTHER |
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Family-based treatments (FBT) for obesity have been shown to be effective in achieving significant weight reductionin overweight or obese children and parents [Altman & Wilfley, 2015]. One component of the current FBT programused in this study that has received little attention is thought training, specifically episodic future thinking (EFT). EFTteaches individuals to pre-experience events, or think prospectively, about future events as if they were happeningnow and has been shown to reduce delay discounting (DD) which is defined as discounting smaller rewards now for a larger reward in the [Daniel, Said, Stanton, & Epstein]. Furthermore, EFT has been shown to help people purchase fewer calories when they are grocery shopping [Hollis-Hansen et al., 2019], thereby displaying potential to be an effective measure in modulating the food environment in homes and may play a role in changing eating behaviors related to weight loss [Appelhaus et al.,2019].
Given the power of EFT in promoting the purchase of fewer calories, it is plausible that EFT training focused around grocery shopping during FBT could help shift one's thought processes towards healthier food choices, promoting behavioral change that has lasting impact on the home environment. Thus, the primary purpose of this study is to assess whether EFT training promotes active behavioral change pertaining to grocery shopping during FBT. In turn,this resulting behavior change could lead to healthier eating behavior and may promote weight loss for the whole family.
We hypothesize:
The study program is organized into 15 sessions. There is a mix of group sessions, individual family in-person sessions, and individual family phone sessions. Each session is outlined below:
WEEK 0 - Baseline Session: In-Lab Group Session - All Baseline sessions were completed as planned in lab.
First, upon arriving to the lab, each dyad will be escorted to a private room and will complete the following:
Following steps 1-4, the families will take part in a group session to learn the core components of the program in presentations by the research staff.
Weeks 1-14 ~ 1 hour; Weekly In-Lab Group Sessions - Due to the COVID 19 outbreak, in-person assessments and interventions are no longer feasible. Therefore, the researchers will carry out these study components remotely. The programs that will be used are phone, Zoom, and Qualtrics.
The day of their assigned parent group session, each family will email the study coordinator a photocopy of their food receipts, receipt forms, and food log. They will self-report weights via email as well.
Children will join a child-only Zoom group video session, and parents will join a parent-only Zoom video session. Each group will be led by a study team member. In these sessions, participants will do the thought training program, and talk to staff and other group members about progress in the program. Each parent-child dyad will meet via Zoom or phone at a separate time with a study team member to complete the case management portion of the program.
Throughout the baseline period, the study team will assess all participants' adherence levels through looking at data from the food logs and the collected receipts.
Once a family has been determined to be adhering to the study protocol, the participant will then be randomly assigned to either the 7- week or 10-week baseline group. After the assigned baseline, participants will be eligible to start the EFT intervention.
An assessment session will take place the week the group starts the intervention, which will consist of 1- Self-reported weights via email 2- Complete surveys: EDE-Q (Parent), KEDS (Child) on Qualtrics 3- Complete EFT cue generation needed for thought training 4- Complete the Delay Discounting Task on Qualtrics and the Virtual Shopping Task via emailed instructions.
5- Review weekly receipts 6- Receive assessment session payment 7. Receive a EFT Cue Retrieval technology tutorial via emailed instructions, or a Zoom or phone session as requested
EFT Cue Retrieval: The experimenter will then train participants in both groups on how to retrieve cues from their cell phone or alternative WiFi device, to pay attention to and think about the cues, and how to adhere to the study's expectations for utilizing to the cues. Participants will be told to use their cues any time they need to, especially around eating episodes, using the prompt response website - Mobile Audio Management and Response Tracker (MAMRT)(Sze, Daniel, Kilanowski, Collins, Epstein, 2015).
Assessment measures must be completed the day of their assigned group sessions. Child and Parent Zoom-based group sessions will be conducted at their scheduled times, as well as scheduled case management.
Week 15 ~ Final Assessment - All assessment measures for week 15 will be conducted remotely, unless COVID-19related restrictions are lifted, in which an in-lab visit for final measurements may be conducted.
Assessment measures must be completed the day of their assigned group sessions. Child and Parent Zoom-based group sessions will be conducted at their scheduled times, as well as scheduled case management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Episodic Future Thinking Group 7-week baseline | Experimental | 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 10-week baseline | Experimental | 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]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Episodic Future Thinking Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 | 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. | Change from Baseline BMI at week 8, 11 and 15 |
| Change in Weight for Parents From Baseline at Weeks 8, 11 and 15 | Weight was measured in lbs | Change from Baseline weight at week 8, 11 and 15 |
| Change in BMI Percentile for Children | Change in BMI percentile for children from 0, 8, 11 and 15 weeks | Baseline, 8, 11 and 15 weeks |
| Change in Weight for Children From Baseline at Weeks 8, 11 and 15 | Weight was measured in lbs and examined as change from baseline in lbs at week 8, 11 and 15 | Change from Baseline weight at week 8, 11 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Delay Discounting for 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. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard Epstein, PhD | State University of New York at Buffalo | Principal Investigator |
| Denise Wilfley, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23917063 | Background | Daniel TO, Stanton CM, Epstein LH. The future is now: comparing the effect of episodic future thinking on impulsivity in lean and obese individuals. Appetite. 2013 Dec;71:120-5. doi: 10.1016/j.appet.2013.07.010. Epub 2013 Jul 31. | |
| 21543607 | Background | Benoit RG, Gilbert SJ, Burgess PW. A neural mechanism mediating the impact of episodic prospection on farsighted decisions. J Neurosci. 2011 May 4;31(18):6771-9. doi: 10.1523/JNEUROSCI.6559-10.2011. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline participants included 7 parent-child dyads. Baseline characteristics are broken down by parent and child information on separate lines.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Parent age, years | Parent information n = 7 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 | 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. | Parents (n = 7) will be analyzed for change in BMI from baseline | Posted | Mean | Standard Deviation | kg/m^2 | Change from Baseline BMI at week 8, 11 and 15 |
|
15 weeks during which families received treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Episodic Future Thinking Group - 7 Week Parents | Parent participants of the family dyad. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Day | Washington University in St. Louis | 314-286-0079 | dayt@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2020 | Jun 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Non-concurrent multiple baseline design;participants will be randomized to a 7 week, or 10 week group with staggered baseline periods followed by 4-8 weeks of the intervention consisting of FBT and EFT. Enrollment is for parent-child dyads.
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|
| Baseline, 10 weeks, 15 weeks |
| 18468941 | Background | Boyer P. Evolutionary economics of mental time travel? Trends Cogn Sci. 2008 Jun;12(6):219-24. doi: 10.1016/j.tics.2008.03.003. Epub 2008 May 28. |
| 25863227 | Background | Daniel TO, Said M, Stanton CM, Epstein LH. Episodic future thinking reduces delay discounting and energy intake in children. Eat Behav. 2015 Aug;18:20-4. doi: 10.1016/j.eatbeh.2015.03.006. Epub 2015 Mar 28. |
| 11728911 | Background | Atance CM, O'Neill DK. Episodic future thinking. Trends Cogn Sci. 2001 Dec 1;5(12):533-539. doi: 10.1016/s1364-6613(00)01804-0. |
| 21249462 | Background | John LK, Loewenstein G, Troxel AB, Norton L, Fassbender JE, Volpp KG. Financial incentives for extended weight loss: a randomized, controlled trial. J Gen Intern Med. 2011 Jun;26(6):621-6. doi: 10.1007/s11606-010-1628-y. Epub 2011 Jan 20. |
| 27095323 | Background | Leahey TM, Fava JL, Seiden A, Fernandes D, Doyle C, Kent K, La Rue M, Mitchell M, Wing RR. A randomized controlled trial testing an Internet delivered cost-benefit approach to weight loss maintenance. Prev Med. 2016 Nov;92:51-57. doi: 10.1016/j.ypmed.2016.04.013. Epub 2016 Apr 17. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Child Age, years | child information n = 7 | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Parent reported sex | Parent information n = 7 | Count of Participants | Participants |
|
| Sex: Female, Male | Child reported Sex | child information n = 7 | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Parent self-reported Ethnicity | Parent information n = 7 | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Child self-reported ethnicity | child information n = 7 | Count of Participants | Participants |
|
| Race (NIH/OMB) | Parent self-reported Race | Parent information n = 7 | Count of Participants | Participants |
|
| Race (NIH/OMB) | Child self-reported race | child information n = 7 | Count of Participants | Participants |
|
| Region of Enrollment | Number | dyads |
|
| Parent Body Mass Index (BMI) | Parent body mass index as calculated BMI = kg/m^2. Overweight is defined for adults as BMI<30 and BMI>=25 and obesity as BMI>=30 | Parent BMI is reported (n = 7) | Mean | Standard Deviation | kg/m^2 |
|
| Child BMI percentile | BMI percentile is used for children rather than BMI, as it is standardized for child age and sex. BMI percentile >=95th is considered obesity for children and BMI>=85 and <95th is considered overweight for children | Child (n = 7) measured BMI percentile | Mean | Standard Deviation | standardized percentile |
|
| OG001 | Episodic Future Thinking 10-week Baseline | 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. |
|
|
|
| Primary | Change in Weight for Parents From Baseline at Weeks 8, 11 and 15 | Weight was measured in lbs | Posted | Mean | Standard Deviation | pounds | Change from Baseline weight at week 8, 11 and 15 |
|
|
|
|
| Primary | Change in BMI Percentile for Children | Change in BMI percentile for children from 0, 8, 11 and 15 weeks | Children (n = 7) analysis | Posted | Mean | Standard Deviation | Standardized percentile | Baseline, 8, 11 and 15 weeks |
|
|
|
|
| Secondary | Delay Discounting for 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. | n = 7 children | Posted | Mean | Standard Deviation | proportion max reward x proportion delay | Baseline, 10 weeks, 15 weeks |
|
|
|
|
| Primary | Change in Weight for Children From Baseline at Weeks 8, 11 and 15 | Weight was measured in lbs and examined as change from baseline in lbs at week 8, 11 and 15 | child | Posted | Mean | Standard Deviation | pounds | Change from Baseline weight at week 8, 11 and 15 |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Episodic Future Thinking Group 7-week Children | Child participants of the family dyad. 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Episodic Future Thinking Group - 10 Week Parents | Parent participants of the family dyad. 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Episodic Future Thinking Group - 10 Week Children | Child participants of the family dyad. 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change in weight (lbs) from 0 to 15 weeks |
|
| change in child BMI percentile from 0 to 11 weeks |
|
| Change in child BMI percentile from baseline to 15 weeks |
|
| Week 15 Area under the curve |
|
| Change in weight (lbs) from 0 to 15 weeks |
|