Overweight and ObesityNCT03393221
Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight
A study testing ER and SBWC in people with Overweight and Obesity, run by Rhode Island Hospital at 1 site in United States.
Trial summary
While the prevalence of overweight and obesity among children and adolescents has plateaued, national data indicate that approximately 35% of children and adolescents continue to struggle with overweight/obesity. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- ER and SBWC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 13-17 years of age
- > 85th percentile for BMI but < a BMI of 50
- speak English
- agree to participation and randomization
Who cannot join
- they are currently in another weight loss program
- have a medical condition that precludes participation in physical activity or adherence to dietary recommendations
- are developmentally delayed such that the intervention will not be appropriate
- are in treatment for a major psychiatric disorder.
- cannot understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Emotion Regulation Among Overweight and Obese Adolescents Attempting to Lose Weight
While the prevalence of overweight and obesity among children and adolescents has plateaued, national data indicate that approximately 35% of children and adolescents continue to struggle with overweight/obesity. While considerable attention has been given to comprehensive behavioral interventions to address obesity in children, there is less empirical evidence demonstrating efficacy of interventions with adolescents. Additionally, there is great variability and limited impact of adolescent weight control interventions which may be attributable to the failure of these interventions to explicitly address emotion regulation abilities that are necessary for weight loss. Notably, adolescents with poorer general emotion regulation have been found to consume more snack/junk food and report greater amounts of sedentary behavior. Poor emotion regulation among adolescents has also been associated with more rapid weight gain and greater BMI. This project adapts a previously validated Emotion Regulation intervention (TRAC) for at-risk adolescents, targeting sexual risk reduction, to focus on weight loss among a sample of overweight and obese adolescents (ages 12 to 18). While sexual risk and weight management are distinct health behaviors, this same model of emotion regulation could be applied to overweight/obese adolescents attempting to lose weight. In fact, data from overweight/obese adolescents attending a past outpatient weight management program (N=124) indicate that 82% of these youth report emotion regulation scores that are comparable to youth with significant mental health problems. Furthermore, higher levels of emotional dysregulation was associated with greater BMI within this same sample. These data suggest that emotion regulation is related to health decision making and will be relevant to the majority of overweight/obese adolescents seeking to lose weight. The current study will be carried out across Phase 1a and 1b. During Phase 1a, the initial acceptability and feasibility of the adapted intervention (HEALTH TRAC) with eight adolescents in an open pilot trial will be evaluated. During Phase 1b, 48 adolescents between the ages of 13-17 years will be randomized to receive either the HEALTH TRAC or standard behavioral weight control intervention (SBWC) and examine the impact on emotion regulation abilities and BMI status over an eight-month period. The information gained in this project will improve understanding of strategies to improve weight loss outcomes among overweight/obsess adolescents and how improving emotion regulation abilities can enhance these interventions.
- Conditions
- Overweight and Obesity
- Being tested
- ER, SBWC
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERBehavioural
Emotion regulation content
SBWCBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SBWC+ER | Experimental | Participants randomized to the Standard Behavioral Weight Control and Emotional Regulation (SBWC+ER) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16. They receive the same information as the Standard Behavioral Weight Control group, but weekly sessions also include elements of TRAC, and it is designed to help teach emotion regulation skills to decrease overeating and sedentary behaviors and increase the likelihood of maintaining diet and exercise behaviors that are taught as part of SBWC interventions. Receives: Behavioral: ER; Behavioral: SBWC |
| SBWC | Active comparator | Participants randomized to the Standard Behavioral Weight Control (SBWC) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16. The intervention includes a dietary plan, a fitness plan, behavioral weight control management that includes self-monitoring, goal-setting, stimulus control strategies, and planning, as well as parental involvement. Receives: Behavioral: SBWC |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI decrease
A significant decrease in participant BMI due to weight loss
Measured: baseline, 4 months, and 8 month follow up
Secondary outcomes (12)
Emotion Regulation
Difficulties in Emotion Regulation Scale (DERS)- a 36-item questionnaire designed to assess multiple aspects of emotion regulation (scale: 1 strongly disagree- 5 strongly agree). Measure yields a total score as well as six scales derived through factor analysis: (1. Nonacceptance of emotional response, 2. Difficulties engaging in goal directed behavior [goals], 3. Impulse control difficulties [impulse], 4. Lack of emotion awareness [awareness], 5. Limited access to emotion regulation strategies [strategies] 6. Lack of emotional clarity [clarity] ).
Measured: baseline, 4 month, and 8 month follow up
Emotion Regulation Strategy Usage
Emotion Regulation Behavior Scale (ERBS)- assesses use of emotion regulation strategies taught in intervention. items include "in the last week, when you were having a strong feeling (e.g., sad, upset, etc.) how often did you...get away from whatever was causing your feeling?..."participants respond on a scale of 1 (never) to 5 (all the time) across 8 items, with higher scores indicating more regulatory behaviors (range: 8-40)
Measured: baseline, 4 month, and 8 month follow up
Emotion Regulation
Affect Dysregulation Scale (ADS)- 24 item scale adapted from the clinician-rated Affect Regulation and Experience q-sort questionnaire, modified with 6-items used to assess frequency of difficulty with affect regulation on 4-point Likert, with higher scores indicating more difficulty with affect (range: 6-36)
Measured: baseline, 4 month, and 8 month follow up
Emotion Regulation
Toronto Alexithymia Scale (TAS)- "20 item instrument that is one of the most commonly used measures of alexithymia. Alexithymia refers to people who have trouble identifying and describing emotions and who tend to minimize emotional experience and focus attention externally.
3 subscales: 1-difficulty describing emotions (5 items-2,4,11,12,17), 2- difficulty identifying emotions (7 items-1,3,6,7,9,13,14), and 3- the tendency of individuals to focus their attention externally (8 items-5,8,10,15,16,18,19,20) "
(Likert scale: 1 completely disagree - 5 completely agree) (Total range: 20-200)
Measured: baseline, 4 month, and 8 month follow up
Distress Tolerance
Behavior Indicator of Resiliency to Distress (BIRD)- Manipulation/measure of distress-tolerance. The first level of the BIRD test lasts 3 minutes. The level begins with a 5 second latency between dot presentations and changes this latency based on performance (correct answers will reduce the latency by 0.5 seconds whereas incorrect answers or non-responses increase the latency by 0.5 seconds). At the conclusion of this level an average latency is calculated to index skill level. The second level lasts five total minutes. Following a brief rest period the final level begins and lasts for 5 minutes. At all points in the final level the participant will have an escape option. The "quit game" on the screen can be clicked at any time. Therefore making the total time for this game roughly 10-15 minutes long. (Amstadter et al, 2011)
Measured: baseline and 4 months
Emotion Regulation
Emotions as a Child scale- "examines parental emotional socialization from both parent and child perspectives across 45-items. This measure generates 5 subscales of emotion socialization including parental encouragement of emotion expression, parental punishing of responses, parental neglect, parental matching, and parental overriding of child's emotions. Reliability of subscales range from .80 to .87"
Measured: baseline, 4 month, and 8 month follow up
Emotion Regulation
Emotion Regulation Checklist (ERC)- "is an instrument for the hetero-evaluation of the level of emotion regulation of children by means of two scales, Emotion Regulation (ER) and Emotional Lability/ Negativity. 24 items that are assessed on a four point Likert scale (1=never, 2=sometimes, 3=often, and 4= almost always). The ERC comprises two scales: one scale contains 8 items to assess ER, while the other scale contains 15 items that measure emotional liability/negativity, including lack of flexibility, emotional activation, reactivity, anger dysregulation, and mood reliability. (L/N α = .96; ER α = .83), and the two scales are significantly correlated (r = -.50, p < .001). One single measurement of ER is generated from the overall scores in both sub-scales (α = .89; Shields \& Cicchetti, 1997)."
Measured: baseline, 4 month, and 8 month follow up
Emotional Eating
Emotional Eating Scale (EES)- "25 item self report measure used to assess the propensity to cope with negative affect by eating. Subjects rate their desire to eat in response to each emotion on 5 point scale from "1"I have no desire to eat"" through "5"I have a very strong desire to eat""" (Range 25- 125, with higher scores indicating more coping with affect by eating)
Measured: baseline, 4 month, and 8 month follow up
Eating Disorders
Eating Disorder Examination Questionnaire (EDEQ)- " 28 item questionnaire that has 2 additional questions for males and 5 additional questions for females. Used to measure eating disorder psychopathology, with higher scores indicating higher eating disorder psychopathy. Provides a measure of the range and severity of eating disorder features. Also has the ability to generate operational eating disorder diagnoses. Used to screen potential participants [Subscales: Restraint (items 1,2,3,4,5), Eating concern (items 7,9,19,20,21), Shape concern (items 6,8,10,11,23,26,27,28), Weight Concern (8,12,22,24,25) ]
Measured: baseline, 4 month, and 8 month follow up
Eating Habits Confidence
Eating Habits Confidence Questionnaire (EHCQ)- "27-item scale questionnaire asks participants to rate confidence in their ability to adhere to specific dietary behaviors. Response set consisted of a 5 point-linkert type scale ranging from 1, ""I know I cannot"" to 5, ""I know I can."" Possible scores of this survey range from 27 to 135, with higher scores indicating higher self-efficacy.
Measured: baseline to 8 months
Eating Behavior
Eating Behaviors Inventory- "Instrument for assessing behaviors that have been theoretically implicated in weight loss (self monitoring of food intake and of weight, refusing offers of food, eating at only one place, shopping from a list) 30 items are included that are each rate with a 5 point scale according to how often it was true for the respondent. Items were scored such that the higher scores always reflected more appropriate eating patterns." (Total range: 30- 150)
Measured: baseline, 4 months, and 8 months
Accelerometer (physical activity)
Majority of studies say at least 5 days per week for at least 8 hours per day to receive accurate data on PA. Device used to measure physical activity using criteria such as time spent in activities performed for various intensities and for the prediction of energy expenditure.
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study startDec 2016
- Primary completionJun 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Hadley, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393221
- Sponsor's protocol ID
- 1R21DK108164-01A1
- Status last verified
- May 2019
- First submitted
- 11 Dec 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hadley W, Houck C, Barker D, Wickham B, Bogner J, Jelalian E. Preliminary Impact of an Adapted Emotion Regulation Intervention for Adolescents with Overweight and Obesity Attempting to Lose Weight. J Dev Behav Pediatr. 2020 Dec;41(9):706-715. doi: 10.1097/DBP.0000000000000837.
PubMed 32740283
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Emotion Regulation Among Overweight and Obese Adolescents Attempting to Lose Weight
- ClinicalTrials.gov ID
- NCT03393221
- Acronym / sponsor ID
- 1R21DK108164-01A1
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While the prevalence of overweight and obesity among children and adolescents has plateaued, national data indicate that approximately 35% of children and adolescents continue to struggle with overweight/obesity. While considerable attention has been given to comprehensive behavioral interventions to address obesity in children, there is less empirical evidence demonstrating efficacy of interventions with adolescents. Additionally, there is great variability and limited impact of adolescent weight control interventions which may be attributable to the failure of these interventions to explicitly address emotion regulation abilities that are necessary for weight loss. Notably, adolescents with poorer general emotion regulation have been found to consume more snack/junk food and report greater amounts of sedentary behavior. Poor emotion regulation among adolescents has also been associated with more rapid weight gain and greater BMI. This project adapts a previously validated Emotion Regulation intervention (TRAC) for at-risk adolescents, targeting sexual risk reduction, to focus on weight loss among a sample of overweight and obese adolescents (ages 12 to 18). While sexual risk and weight management are distinct health behaviors, this same model of emotion regulation could be applied to overweight/obese adolescents attempting to lose weight. In fact, data from overweight/obese adolescents attending a past outpatient weight management program (N=124) indicate that 82% of these youth report emotion regulation scores that are comparable to youth with significant mental health problems. Furthermore, higher levels of emotional dysregulation was associated with greater BMI within this same sample. These data suggest that emotion regulation is related to health decision making and will be relevant to the majority of overweight/obese adolescents seeking to lose weight. The current study will be carried out across Phase 1a and 1b. During Phase 1a, the initial acceptability and feasibility of the adapted intervention (HEALTH TRAC) with eight adolescents in an open pilot trial will be evaluated. During Phase 1b, 48 adolescents between the ages of 13-17 years will be randomized to receive either the HEALTH TRAC or standard behavioral weight control intervention (SBWC) and examine the impact on emotion regulation abilities and BMI status over an eight-month period. The information gained in this project will improve understanding of strategies to improve weight loss outcomes among overweight/obsess adolescents and how improving emotion regulation abilities can enhance these interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBWC+ER | Experimental | Behavioral: ER, Behavioral: SBWCParticipants randomized to the Standard Behavioral Weight Control and Emotional Regulation (SBWC+ER) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16. They receive the same information as the Standard Behavioral Weight Control group, but weekly sessions also include elements of TRAC, and it is designed to help teach emotion regulation skills to decrease overeating and sedentary behaviors and increase the likelihood of maintaining diet and exercise behaviors that are taught as part of SBWC interventions. |
| SBWC | Active comparator | Behavioral: SBWCParticipants randomized to the Standard Behavioral Weight Control (SBWC) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16. The intervention includes a dietary plan, a fitness plan, behavioral weight control management that includes self-monitoring, goal-setting, stimulus control strategies, and planning, as well as parental involvement. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 13-17 years of age
- > 85th percentile for BMI but < a BMI of 50
- speak English
- agree to participation and randomization
Key exclusion criteria (5 listed)
- they are currently in another weight loss program
- have a medical condition that precludes participation in physical activity or adherence to dietary recommendations
- are developmentally delayed such that the intervention will not be appropriate
- are in treatment for a major psychiatric disorder.
- cannot understand English
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 |
|---|---|---|
| EREmotion regulation content | Behavioural | SBWC+ER |
| SBWC | Behavioural | SBWC, SBWC+ER |
Primary outcome
BMI decrease
Time frame: baseline, 4 months, and 8 month follow up
A significant decrease in participant BMI due to weight loss
12 secondary outcomes
Emotion Regulation
Time frame: baseline, 4 month, and 8 month follow up
Emotion Regulation Strategy Usage
Time frame: baseline, 4 month, and 8 month follow up
Emotion Regulation
Time frame: baseline, 4 month, and 8 month follow up
Emotion Regulation
Time frame: baseline, 4 month, and 8 month follow up
Distress Tolerance
Time frame: baseline and 4 months
Emotion Regulation
Time frame: baseline, 4 month, and 8 month follow up
Emotion Regulation
Time frame: baseline, 4 month, and 8 month follow up
Emotional Eating
Time frame: baseline, 4 month, and 8 month follow up
Eating Disorders
Time frame: baseline, 4 month, and 8 month follow up
Eating Habits Confidence
Time frame: baseline to 8 months
Eating Behavior
Time frame: baseline, 4 months, and 8 months
Accelerometer (physical activity)
Time frame: baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 32740283Hadley W, Houck C, Barker D, Wickham B, Bogner J, Jelalian E. Preliminary Impact of an Adapted Emotion Regulation Intervention for Adolescents with Overweight and Obesity Attempting to Lose Weight. J Dev Behav Pediatr. 2020 Dec;41(9):706-715. doi: 10.1097/DBP.0000000000000837.
- 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.
Wendy Hadley, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ER and SBWC in people with Overweight and Obesity, run by Rhode Island Hospital 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 4 inclusion and 5 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 19 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BMI decrease (time frame: baseline, 4 months, and 8 month follow up). 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 NCT03393221, which also lists 1 linked publication.
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 19 Oct 2020.