Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04848532 |
| Other study ID # |
2005007834 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2021 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Drexel University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study evaluates the associations between baseline decision-making processes, engagement
in problematic dietary practices, and post-intervention weight loss outcomes among
adolescents. Results from the study will provide specific direction for what components
should comprise future decision-making interventions for adolescents with overweight/obesity.
Description:
Adolescent overweight and obesity (AOB; i.e., a body mass index (BMI) greater than 85th
percentile for age, height, and gender) affects 34.5% of adolescents. Over 80% of obese
adolescents will become obese adults and experience increased risk of cardiovascular disease,
type 2 diabetes, gallbladder disease, and some forms of cancer. Because of contraindications
and hesitations to pursue psychopharmacology or bariatric surgery, behavioral interventions
are the first-line treatment for AOB. Unfortunately, adolescent outcomes from pediatric
behavioral obesity treatments are poor. In fact, the modal weight loss in behavioral
interventions is less than a single BMI point, and many participants lose no weight at all.
Outcomes in adolescents are worse than those found in younger children and adults. Notably,
the vast majority of existing interventions tested in adolescents are designed for younger
children, which may preclude an adolescent's success in these interventions. Successful
behavioral AOB interventions may require augmentations that address developmental concerns
unique to adolescence. For example, research has shown that, in contrast to younger children,
many adolescents are making their own food decisions and are thus more likely to engage in
problematic eating behaviors during treatment. As a necessary step towards developing
specialized interventions for AOB, it is critical to understand the underlying mechanisms of
continued engagement in problematic eating behaviors during AOB interventions.
Three types of problematic eating behaviors are strongly linked (cross-sectionally and
longitudinally) with AOB. First, reward-driven overeating (i.e., frequently eating
energy-dense foods) results in excess calorie intake, which, in turn, produces adiposity
during childhood and adolescence. Second, loss-of-control eating (LOC; the experience of not
being able to stop eating once started) is an exceptionally strong predictor of excess weight
gain, i.e., an additional 2.4kg per year compared to peers without LOC. Third, rigid dietary
restriction involves skipping meals and cutting out food groups for the purposes of weight
regulation, but instead results in intense feelings of deprivation. As a result, rigid
dietary restriction has the paradoxical effect of calorie overconsumption, excess weight
gain, and poor outcomes from pediatric obesity treatment. Taken together, findings indicate
that elucidating the drivers of these three problematic eating behaviors is critical to
improving AOB treatment outcomes.
An aberrant decision-making framework represents an attractive paradigm for understanding the
above-described problematic eating behaviors, especially given that they all run counter to
adolescents' intentions and well-being. There are several aberrant decision-making processes
endemic to the adolescent developmental period. Three of these processes in particular appear
to be directly linked to the three problematic eating behaviors described above. To the
extent that aberrant decision-making produces problematic eating behavior, aberrant
decision-making can also be hypothesized to predict poor weight loss outcomes. Below, three
aberrant decision-making processes and their links to problematic eating behavior are
described.
Increased delay discounting. Delay discounting refers to the tendency to discount greater,
later rewards in favor of smaller, sooner rewards. A combination of greater sensitivity to
reward and slow development of self-regulatory neural processes contributes to especially
high discounting rates in some adolescents. Relatively higher discounting rates may produce
reward-driven eating, i.e., frequent consumption of energy-dense foods (e.g., high-fat, high
sugar foods), while discounting the future reward (e.g., weight loss) that would be derived
from forgoing immediate gratification. Indeed, a recent meta-analysis concluded that higher
discounting rates were strongly cross-sectionally linked with AOB. Although behavioral weight
loss programs discourage consumption of energy-dense foods, psychological strategies for how
to prioritize long-term over short-term rewards are not provided. Thus, delay discounting
likely contributes to continued reward-driven eating during treatment. However, no studies
have tested whether delay discounting predicts reward-driven overeating (and its effect on
weight) during AOB treatment.
Affect-driven impulsivity. Affect-driven impulsivity refers to a tendency to choose
maladaptive behaviors geared towards the immediate cessation of a negative affective state,
despite negative consequences. Affect-driven impulsivity likely drives continued LOC eating
during treatment, precluding successful weight loss. Affect-driven impulsivity is a
cross-sectional predictor of AOB, but it may be a particularly strong driver of LOC eating
because compulsive eating serves the function of reducing distress. Although no studies have
compared adolescents with and without LOC on affect-driven impulsivity, adolescents with LOC
eating demonstrate overall higher levels of emotional reactivity and emotional eating. LOC
eating resulting from affect-driven impulsivity may continue to occur during treatment
because little treatment content focuses on skills for tolerating negative affect. Dr.
Manasse's work demonstrates that increased affect-driven impulsivity predicts poor outcomes
from adult binge eating treatment. However, no studies have examined whether affect-driven
impulsivity predicts (1) engagement in LOC during treatment or (2) poor AOB treatment
outcomes.
Perseverative decision-making. Perseverative decision-making is characterized by weakened
ability to stop engagement in habitual behaviors despite changing contingencies. Highly
perseverative decision-making may contribute to repeated engagement in rigid dietary
restriction (i.e., setting rigid calorie goals, cutting out specific foods) that increase
deprivation. This deprivation, in turn, leads to episodes of overeating that preclude
successful caloric restriction. Those who show highly perseverative decision-making continue
engaging in this rigid dietary restriction behavior despite the fact that it ultimately
delivers the opposite of its intended effect. Indeed, perseverative decision-making and rigid
dieting are associated with the presence of LOC eating, and perseveration is
cross-sectionally associated with obesity in adolescence. Despite the established links
between perseverative decision-making with unhealthy dieting and excess weight, no studies
have examined whether perseverative decision-making underlies continued engagement in
problematic dietary restriction during treatment and predicts poor outcomes.
To inform the development of tailored intervention approaches, the current study, funded by
the National Institutes of Health, aims to elucidate the specific aberrant decision-making
processes associated with three problematic eating behaviors and weight loss outcomes.
Results from the study will provide specific direction for what components (e.g., strategies
for tolerating emotional distress or promoting flexible thinking) should comprise a future
decision-making intervention for AOB and for whom (e.g., those with LOC, those who engage in
problematic restriction) certain components would be most relevant. Given that LOC eating is
a robust predictor of excess weight gain but only 20-30% of those with AOB endorse LOC
eating, the study team will oversample individuals with clinically significant LOC, i.e., the
study will recruit a total of 80 adolescents (ages 14-18) with overweight/obesity, half of
whom (n=40) endorse clinically significant (i.e., at least once weekly) LOC eating and the
other half of whom (n=40) endorse subclinical LOC or no LOC. All participants will receive a
16-week group-based, remotely delivered behavioral weight loss intervention and complete a
6-month follow-up. Decision-making measures will be administered at baseline. Problematic
eating behaviors and weight will be assessed at all time points.
