Overweight and ObesityNCT03731325
Episodic Future Thinking and Weight-Loss
A study testing Episodic Future Thinking Group in people with Overweight and Obesity, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Episodic Future Thinking Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child age between 10-14
- Child height and weight that calculates to a BMI above the 85th percentile (BMI in overweight/obesity range)
- Parent height and weight that calculates to a BMI above 18
- Possession of at least one electronic device (per family) with WiFi capabilities (e.g. smartphone, tablet, computer)
- Home internet access
- Motivation to lose weight
Who cannot join
- Disordered eating patterns (e.g. binge-eating disorder, extreme weight-loss behaviors)
- A family history of eating disorders (siblings, children, parents, or grandparents)
- Medical conditions that are known to interfere with weight-loss (e.g. type 1 diabetes, thyroid disease)
- Medical conditions that may affect their ability to use the computer for a prolonged period of time or follow study protocol
- Psychopathology or disabilities that would limit adherence to protocol (e.g. depression, suicidality, ADHD). Participant will only be excluded if the disability would not allow them to adhere to protocol. Just having the disability does not exclude them. Suicidality would be automatically be exclusionary)
- Substance use, abuse, or dependence (e.g. binge drinkers, illicit substance users, alcoholics)
Show all 13Show fewer
- Plans to start or stop a medication that may affect appetite/weight-loss during the intervention period
- Have started a medication within 6 months that is affecting appetite/weight-loss
- Plans to move out of the area during the treatment period
- Pregnancy/breastfeeding or plans of becoming pregnant during the study period
- Is participating in another weight-loss program
- Can not successfully record eating behavior in the MyFitnessPal app
- A) Had bariatric surgery less than one year ago B) If the potential participant had bariatric surgery over a year ago, their weight has not been stable for at least 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: The Effect of Episodic Future Thinking on Weight-Loss
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.
Read more
We hypothesize:
- There will be a reduction in BMI for adults/percent over BMI for children and weight from baseline
- There will be a reduction in delay discounting for children
Read the detailed description
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:
- Have height and weight measured.
- Complete surveys: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child)
- Complete the Delay Discounting Task, the Online Grocery Shopping Task, and Home Food Inventory. A letter was sent to each family explaining the change from in-home visits with the Cupboard inventory to the self-completed Home Food Inventory, due to growing concern over COVID-19.
- Receive first assessment payment ($40 dollars)
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.
- During the 15-week intervention, participants will be asked to log their activity related to the program in food logs.
- Researchers will access the information and send feedback to the participants (via text, phone, and/or email) to help them succeed in 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.
- Self-reported heights and weights
- Complete surveys on Qualtrics: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child),Formative Questionnaire, TT Frequency of Use
- Complete the Delay Discounting Task, Shelf Life Inventory, and Home Food Inventory on Qualtrics, and the Virtual Shopping Task via emailed instructions.
- Review weekly receipts and receive payment if applicable ($25 dollars) via check request, Amazon Pay or Forte.
- Receive final assessment session payment ($45 dollars) via check request, Amazon Pay or Forte.
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.
- Conditions
- Overweight and Obesity
- Being tested
- Episodic Future Thinking Group
- Keywords
- Episodic future thinking, Obesity, Family based treatment
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Future Thinking GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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]. Receives: Behavioral: Episodic Future Thinking Group |
| 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]. Receives: Behavioral: Episodic Future Thinking Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline weight at week 8, 11 and 15
Secondary outcomes (1)
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.
Measured: Baseline, 10 weeks, 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start31 May 2019
- Primary completion20 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Washington University School of Medicine
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard Epstein, PhD, Principal investigator, State University of New York at BuffaloDenise Wilfley, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731325
- Sponsor's protocol ID
- 201807151
- Other IDs
- R01HD080292
- Status last verified
- Sep 2024
- First submitted
- 30 Oct 2018
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23917063Benoit 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.
PubMed 21543607Boyer 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.
PubMed 18468941Daniel 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.
PubMed 25863227Atance 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.
PubMed 11728911John 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.
PubMed 21249462Leahey 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.
PubMed 27095323
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Episodic Future Thinking on Weight-Loss
- ClinicalTrials.gov ID
- NCT03731325
- Acronym / sponsor ID
- 201807151
- Conditions
- Overweight and Obesity
- Keywords
- Episodic future thinking, Obesity, Family based treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Washington University School of Medicine
- Study start
- 31 May 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- There will be a reduction in BMI for adults/percent over BMI for children and weight from baseline
- There will be a reduction in delay discounting for children
Detailed description
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:
- Have height and weight measured.
- Complete surveys: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child)
- Complete the Delay Discounting Task, the Online Grocery Shopping Task, and Home Food Inventory. A letter was sent to each family explaining the change from in-home visits with the Cupboard inventory to the self-completed Home Food Inventory, due to growing concern over COVID-19.
- Receive first assessment payment ($40 dollars)
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.
- During the 15-week intervention, participants will be asked to log their activity related to the program in food logs.
- Researchers will access the information and send feedback to the participants (via text, phone, and/or email) to help them succeed in 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.
- Self-reported heights and weights
- Complete surveys on Qualtrics: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child),Formative Questionnaire, TT Frequency of Use
- Complete the Delay Discounting Task, Shelf Life Inventory, and Home Food Inventory on Qualtrics, and the Virtual Shopping Task via emailed instructions.
- Review weekly receipts and receive payment if applicable ($25 dollars) via check request, Amazon Pay or Forte.
- Receive final assessment session payment ($45 dollars) via check request, Amazon Pay or Forte.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Episodic Future Thinking Group 7-week baseline | Experimental | Behavioral: Episodic Future Thinking GroupThe 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 | Behavioral: Episodic Future Thinking GroupThe 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]. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child age between 10-14
- Child height and weight that calculates to a BMI above the 85th percentile (BMI in overweight/obesity range)
- Parent height and weight that calculates to a BMI above 18
- Possession of at least one electronic device (per family) with WiFi capabilities (e.g. smartphone, tablet, computer)
- Home internet access
Key exclusion criteria (13 listed)
- Disordered eating patterns (e.g. binge-eating disorder, extreme weight-loss behaviors)
- A family history of eating disorders (siblings, children, parents, or grandparents)
- Medical conditions that are known to interfere with weight-loss (e.g. type 1 diabetes, thyroid disease)
- Medical conditions that may affect their ability to use the computer for a prolonged period of time or follow study protocol
- Psychopathology or disabilities that would limit adherence to protocol (e.g. depression, suicidality, ADHD). Participant will only be excluded if the disability would not allow them to adhere to protocol. Just having the disability does not exclude them. Suicidality would be automatically be exclusionary)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Episodic Future Thinking GroupParticipants 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. | Behavioural | Episodic Future Thinking Group 10-week baseline, Episodic Future Thinking Group 7-week baseline |
Primary outcome
Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15
Time frame: Change from Baseline BMI at week 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 in Weight for Parents From Baseline at Weeks 8, 11 and 15
Time frame: Change from Baseline weight at week 8, 11 and 15
Weight was measured in lbs
Change in BMI Percentile for Children
Time frame: Baseline, 8, 11 and 15 weeks
Change in BMI percentile for children from 0, 8, 11 and 15 weeks
Change in Weight for Children From Baseline at Weeks 8, 11 and 15
Time frame: Change from Baseline weight at week 8, 11 and 15
Weight was measured in lbs and examined as change from baseline in lbs at week 8, 11 and 15
1 secondary outcome
Delay Discounting for Children
Time frame: Baseline, 10 weeks, 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23917063Daniel 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.
- Background: PubMed 21543607Benoit 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.
- Background: PubMed 18468941Boyer 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.
- Background: PubMed 25863227Daniel 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.
- Background: PubMed 11728911Atance 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.
- Background: PubMed 21249462John 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.
- Background: PubMed 27095323Leahey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Epstein, PhD principal investigator
State University of New York at Buffalo
Denise Wilfley, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Future Thinking Group in people with Overweight and Obesity, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 (time frame: Change from Baseline BMI at week 8, 11 and 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03731325, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.