Overweight Clinical Trial
Official title:
Adaptation and Evaluation of a Family-Based Mindful Eating Intervention for Overweight Adolescents
With currently 35% of U.S. adolescents being overweight and one in six having metabolic syndrome, adolescent obesity is one of the major global health challenges of the 21st century. Few enduring treatment strategies have been identified in adolescent populations and the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in adolescent behavior change. A critical need exists to expand treatment development efforts beyond traditional education and cognitive-behavioral programs and to explore alternative treatment models for adolescent obesity. Meditation-based mindful eating programs may represent a unique and novel scientific approach to the current adolescent obesity epidemic as they address key psychological variables affecting weight. Furthermore, the recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of this intervention to include broader factors thought to influence adolescent health outcomes. Thus, we propose to develop a mindful eating approach to eating behavior and weight loss specifically tailored for adolescents and their families. The first phase of our three phase development process will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an established mindful eating program currently being used with adult populations. We will then develop a 'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a family systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful Eating-A to include family factors that influence adolescent eating behaviors. The second design phase will consist of an initial test of both intervention components to provide feedback on usefulness and acceptability (N = 10 families). The final phase will examine the overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least one parent. Within this examination, post-treatment and 3-month follow-up comparisons across the two treatment approaches will be made and effect sizes within and between treatments will be assessed.
Adolescent obesity is one of the major global health challenges of the 21st century.
Currently, 35% of adolescents are overweight (BMI > 85th percentile), and one in six are
diagnosed with metabolic syndrome. While the adoption and maintenance of healthful dietary
practices has been identified as a high priority topic for future research, few enduring
treatment strategies have been identified. The cause of adolescent obesity is
multi-factorial; psychological and family factors largely contribute to this epidemic along
with biological and environmental influences. However, the majority of standard weight loss
programs fail to adequately address the impact of psychological factors on eating behavior
and the beneficial contribution of parental involvement in making dietary change in
overweight adolescent populations.
Meditation-based programs may improve the efficacy of more established weight-loss
interventions for adolescents by addressing key psychological variables affecting weight.
Mindfulness-Based Stress Reduction (MBSR) is a well-established, systematic patient-centered
educational approach that uses training in mindfulness meditation to increase awareness of
and the ability to respond skillfully to experiences that contribute to emotional distress
and maladaptive behavior. The efficacy of MBSR in reducing psychological distress and
symptoms of stress in adults has been consistently shown in controlled studies. Significant
improvements in physiological measures related to metabolic syndrome including blood
pressure, cholesterol, and glycemic control have also been demonstrated. Similar meditation
programs have been successfully implemented with adolescents to address problems such as
hypertension, depression, and eating behaviors. Furthermore, the recent expansion of
mindfulness programs to include family relationships shows the immense potential for
broadening the customarily individual focus of meditation-based interventions to include
broader factors thought to influence adolescent health outcomes. This is important given that
greater involvement of the family is thought to increase the effectiveness of interventions
aimed at adolescent weight control, weight maintenance and weight loss.
Recently, researchers have begun to modify the MBSR program specifically for populations
attempting to make dietary health changes. One newly modified program for adults is Mindful
Eating & Living (MEAL), a brief 6-session program designed to teach skills which can lead to
increased awareness of eating, emotions, and judgment. Preliminary data from our own research
with adults shows significant changes in eating behaviors and other obesity related problems,
including reduced psychological distress, regulation of intake patterns, disordered eating,
improved metabolic regulation, and weight loss.
Although theoretically compelling, mindful eating interventions have never been examined with
an overweight adolescent population. Thus, an unprecedented opportunity exists to develop a
systematic program of research investigating a mindfulness approach to eating behavior and
weight loss specifically tailored for adolescents and their families. This is critical given
that adolescence is a period with special developmental considerations, and it is not clear
that weight loss programs developed for children or adults are effective with adolescents.
Interventions aimed at adolescent eating behaviors have met with mixed success, and it has
been theorized that this may be due, in part, to an inadequate understanding of the factors
(e.g. psychological and family-based) associated with eating behaviors among adolescents that
need to be addressed in interventions. To address these gaps, this study proposes to
systematically adapt, pilot, refine, and evaluate a developmentally appropriate Mindful
Eating intervention for overweight adolescents based on the current protocol format taught in
the adult MEAL program. We have designed a three-phase iterative development process that
includes: 1) community key informant and consultant input; 2) beta-testing and further
refinement of the program; and 3) formal pilot testing. Study aims include:
Aim 1: Adapt a mindful eating intervention protocol (Mindful Eating -A) for an overweight
adolescent population (BMI ≥ 85th percentile), ages 14-17. The intervention will be tailored
to the unique developmental challenges of adolescence, suitable for use in applied community
settings, and demonstrate feasibility and acceptability.
Aim 2: Develop a 'family enhanced mindful eating -A' (Mindful Eating -A+F) intervention
protocol that integrates a family systems perspective into Mindful Eating -A. The goal is to
expand the focus of Mindful Eating -A to include family factors that influence adolescent
eating behaviors. These include food-related parenting styles, food organization behaviors,
family support, and the parents' own eating-related behaviors. Mindful Eating -A+F will
demonstrate feasibility, and acceptability, and will be suitable for use in applied community
settings.
Aim 3: To examine the overall efficacy of the optimized Mindful Eating -A+F, relative to the
Mindful Eating -A intervention. Within this examination, post-treatment and 3-month follow-up
comparisons across the two treatment approaches will be made. Effect sizes within and between
treatments will be assessed. We expect that Mindful Eating -A+F will show stronger and more
enduring effects than Mindful Eating -A alone on adolescent outcomes. Primary outcomes
include adolescent weight, BMI, and eating behaviors. Secondary outcomes include adolescent's
markers of metabolic syndrome, psychological distress, family barriers, and mindfulness.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Terminated |
NCT03299881 -
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
|
N/A | |
Completed |
NCT02805478 -
Fat-Associated Cardiovascular Organ Dysfunction
|
||
Active, not recruiting |
NCT02558920 -
Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
|
||
Completed |
NCT03759743 -
Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
|
N/A | |
Completed |
NCT03610958 -
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
|
N/A | |
Completed |
NCT03678766 -
CHARGE: Controlling Hunger and ReGulating Eating
|
N/A | |
Completed |
NCT04430465 -
Effects of Wholegrains on Children's Health (KORN)
|
N/A | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT05376865 -
Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
|
N/A | |
Completed |
NCT03625427 -
Effect of Palmitoleic Acid on C-reactive Protein
|
N/A | |
Active, not recruiting |
NCT03435445 -
Online Platform for Healthy Weight Loss (POEmaS)
|
N/A | |
Enrolling by invitation |
NCT05576116 -
Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics
|
N/A | |
Recruiting |
NCT05249465 -
Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
|
N/A | |
Active, not recruiting |
NCT06023095 -
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
|
Phase 1 | |
Completed |
NCT03648892 -
Brain Dopamine Function in Human Obesity
|
Early Phase 1 | |
Not yet recruiting |
NCT05751993 -
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
|
N/A | |
Recruiting |
NCT02887950 -
Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause
|
N/A | |
Terminated |
NCT02796144 -
MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
|
Phase 4 | |
Completed |
NCT02829229 -
Community-based Obesity Treatment in African American Women After Childbirth
|
N/A |