Overweight and Obesity
Conditions
Keywords
Episodic future thinking, Obesity, Family based treatment
Brief summary
Family-based treatments (FBT) for obesity have been shown to be effective in achieving significant weight reductionin overweight or obese children and parents \[Altman & Wilfley, 2015\]. 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: 1. Have height and weight measured. 2. Complete surveys: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child) 3. 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. 4. 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. 1. 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. 2. 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. 1. During the 15-week intervention, participants will be asked to log their activity related to the program in food logs. 2. 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. 1. Self-reported heights and weights 2. Complete surveys on Qualtrics: Consideration of Future Consequences Scale (CFCS), EDE-Q (Parent), KEDS (Child),Formative Questionnaire, TT Frequency of Use 3. Complete the Delay Discounting Task, Shelf Life Inventory, and Home Food Inventory on Qualtrics, and the Virtual Shopping Task via emailed instructions. 4. Review weekly receipts and receive payment if applicable ($25 dollars) via check request, Amazon Pay or Forte. 5. 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.
Interventions
BEHAVIORALEpisodic 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Washington University School of Medicine
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * 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 Exclusion: * 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 | 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 | Change from Baseline weight at week 8, 11 and 15 | Weight was measured in lbs |
| Change in BMI Percentile for Children | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delay Discounting for Children | Baseline, 10 weeks, 15 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Episodic Future Thinking Group 10-week Baseline | Episodic Future Thinking Group 7-week Baseline | Total |
|---|---|---|---|
| Age, Continuous | 10.7 years STANDARD_DEVIATION 0.6 | 10.5 years STANDARD_DEVIATION 0.6 | 10.6 years STANDARD_DEVIATION 0.5 |
| Child BMI percentile | 95.7 standardized percentile STANDARD_DEVIATION 3.1 | 95.5 standardized percentile STANDARD_DEVIATION 4.7 | 95.6 standardized percentile STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parent Body Mass Index (BMI) | 36.9 kg/m^2 STANDARD_DEVIATION 7.9 | 32.7 kg/m^2 STANDARD_DEVIATION 16.8 | 34.5 kg/m^2 STANDARD_DEVIATION 12.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 3 dyads | 4 dyads | 7 dyads |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 3 |
Outcome results
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.
Time frame: Change from Baseline BMI at week 8, 11 and 15
Population: Parents (n = 7) will be analyzed for change in BMI from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking 10-week Baseline | Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 | Parent Baseline BMI | 36.9 kg/m^2 | Standard Deviation 7.9 |
| Episodic Future Thinking 10-week Baseline | Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 | Change in parent BMI from baseline to week 15 | -2.6 kg/m^2 | Standard Deviation 0.9 |
| Episodic Future Thinking 10-week Baseline | Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 | Change in Parent BMI from baseline to week 11 | -2.2 kg/m^2 | Standard Deviation 0.9 |
| Episodic Future Thinking 10-week Baseline | Change in BMI for Parent Participants From Baseline at Weeks 8, 11 and 15 | Change in parent BMI from baseline to week 8 | -1.9 kg/m^2 | Standard Deviation 1 |
Comparison: Change in parent BMI from baseline at 8,11 to 15 weeksp-value: <0.01ANOVA
Primary
Change in BMI Percentile for Children
Change in BMI percentile for children from 0, 8, 11 and 15 weeks
Time frame: Baseline, 8, 11 and 15 weeks
Population: Children (n = 7) analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking Group 7-week Baseline | Change in BMI Percentile for Children | Baseline Child BMI percentile | 95.5 Standardized percentile | Standard Deviation 4.8 |
| Episodic Future Thinking Group 7-week Baseline | Change in BMI Percentile for Children | Change in child BMI percentile from baseline to 8 weeks | -1.8 Standardized percentile | Standard Deviation 2.8 |
| Episodic Future Thinking Group 7-week Baseline | Change in BMI Percentile for Children | change in child BMI percentile from 0 to 11 weeks | -1.7 Standardized percentile | Standard Deviation 2.9 |
| Episodic Future Thinking Group 7-week Baseline | Change in BMI Percentile for Children | Change in child BMI percentile from baseline to 15 weeks | -1.3 Standardized percentile | Standard Deviation 3.9 |
| Episodic Future Thinking 10-week Baseline | Change in BMI Percentile for Children | Change in child BMI percentile from baseline to 15 weeks | -4.3 Standardized percentile | Standard Deviation 4.5 |
| Episodic Future Thinking 10-week Baseline | Change in BMI Percentile for Children | Baseline Child BMI percentile | 95.7 Standardized percentile | Standard Deviation 3.1 |
| Episodic Future Thinking 10-week Baseline | Change in BMI Percentile for Children | change in child BMI percentile from 0 to 11 weeks | -4.9 Standardized percentile | Standard Deviation 6.4 |
| Episodic Future Thinking 10-week Baseline | Change in BMI Percentile for Children | Change in child BMI percentile from baseline to 8 weeks | -4.3 Standardized percentile | Standard Deviation 5.9 |
Comparison: Repeated measures ANOVA for child BMI percentile at 0, 8, 11 and 15 weeksp-value: 0.06ANOVA
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
Time frame: Change from Baseline weight at week 8, 11 and 15
Population: child
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking Group 7-week Baseline | 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 3.2 |
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking 10-week Baseline | Change in Weight for Children From Baseline at Weeks 8, 11 and 15 | Change in weight (lbs) from 0 to 8 weeks | -2.50 pounds | Standard Deviation 4.3 |
| Episodic Future Thinking 10-week Baseline | Change in Weight for Children From Baseline at Weeks 8, 11 and 15 | Change in weight (lbs) from 0 to 11 weeks | -1.73 pounds | Standard Deviation 6.23 |
| Episodic Future Thinking 10-week Baseline | Change in Weight for Children From Baseline at Weeks 8, 11 and 15 | Change in weight (lbs) from 0 to 15 weeks | -1.77 pounds | Standard Deviation 4.85 |
p-value: 0.64ANOVA
Primary
Change in Weight for Parents From Baseline at Weeks 8, 11 and 15
Weight was measured in lbs
Time frame: Change from Baseline weight at week 8, 11 and 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking Group 7-week Baseline | 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 |
| Episodic Future Thinking 10-week Baseline | Change in Weight for Parents From Baseline at Weeks 8, 11 and 15 | Change in weight (lbs) from 0 to 11 weeks | -9.1 pounds | Standard Deviation 2.1 |
| Episodic Future Thinking 10-week Baseline | Change in Weight for Parents From Baseline at Weeks 8, 11 and 15 | Change in weight (lbs) from 0 to 8 weeks | -7.2 pounds | Standard Deviation 3 |
| Episodic Future Thinking 10-week Baseline | Change in Weight for Parents From Baseline at Weeks 8, 11 and 15 | Change in weight (lbs) from 0 to 15 weeks | -11.7 pounds | Standard Deviation 2.7 |
Comparison: repeated measures analysis of variance for time (0,8,11,15 weeks) for weight change (lbs)p-value: 0.003ANOVA
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.
Time frame: Baseline, 10 weeks, 15 weeks
Population: n = 7 children
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking Group 7-week Baseline | Delay Discounting for Children | Baseline Area Under the curve | 0.28 proportion max reward x proportion delay | Standard Deviation 0.13 |
| Episodic Future Thinking Group 7-week Baseline | Delay Discounting for Children | Week 10 Area under the curve | 0.34 proportion max reward x proportion delay | Standard Deviation 0.17 |
| Episodic Future Thinking Group 7-week Baseline | Delay Discounting for Children | Week 15 Area under the curve | 0.36 proportion max reward x proportion delay | Standard Deviation 0.12 |
| Episodic Future Thinking 10-week Baseline | Delay Discounting for Children | Baseline Area Under the curve | 0.22 proportion max reward x proportion delay | Standard Deviation 0.06 |
| Episodic Future Thinking 10-week Baseline | Delay Discounting for Children | Week 10 Area under the curve | 0.35 proportion max reward x proportion delay | Standard Deviation 0.15 |
| Episodic Future Thinking 10-week Baseline | Delay Discounting for Children | Week 15 Area under the curve | 0.35 proportion max reward x proportion delay | Standard Deviation 0.14 |
Comparison: repeated measures ANOVA, reporting repeated measures effect onlyp-value: 0.07ANOVA