CBT + Exercise for Diabetes Prevention in Adolescents
(CBTeX Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Colorado State University
Must not be taking: Insulin sensitizers, Steroids
Disqualifiers: Diabetes, Cardiovascular, Renal, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.
Will I have to stop taking my current medications?
The trial requires that participants do not take insulin sensitizers, weight loss medications, or chronic steroids. If you are on these medications, you would need to stop them to join the study.
What data supports the effectiveness of the treatment CBT + Exercise for Diabetes Prevention in Adolescents?
Research shows that cognitive-behavioral therapy (CBT) can help reduce depression, which is linked to better insulin sensitivity and weight management in adolescents at risk for type 2 diabetes. Additionally, physical exercise is known to improve insulin sensitivity, which can help prevent type 2 diabetes.
12345Is CBT combined with exercise safe for adolescents?
Exercise is generally considered safe with nearly no side effects, and it is recommended for both adults and children to improve health. However, individuals with specific conditions like type 2 diabetes should have a medical evaluation before starting an exercise program to prevent injury or complications.
678910How is the CBT + Exercise treatment for diabetes prevention in adolescents different from other treatments?
This treatment is unique because it combines Cognitive-Behavioral Therapy (CBT) to address depression symptoms with exercise training, which together may improve both mental health and insulin sensitivity, offering a more comprehensive approach to preventing type 2 diabetes in adolescents.
311121314Eligibility Criteria
This trial is for teenage girls aged 12-17 who are at risk for type 2 diabetes due to family history, show signs of depression, and have a higher body weight for their age. They shouldn't have diabetes or major medical conditions, mental disorders like schizophrenia or eating disorders, be on mood-altering medications, or be pregnant.Inclusion Criteria
I am between 12 and 17 years old.
I am female.
I have a parent, sibling, or grandparent with Type 2 Diabetes.
+2 more
Exclusion Criteria
I do not have major health issues that prevent me from exercising.
Pregnancy, nursing
You have been diagnosed with certain mental health conditions including conduct disorder, substance abuse/dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia/bulimia, and schizophrenia.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Cognitive-Behavioral Therapy
Participants undergo a 6-week cognitive-behavioral therapy intervention with weekly 1-hour group sessions
6 weeks
6 visits (in-person)
Exercise Training
Participants undergo a 6-week exercise training intervention with weekly 1-hour group sessions
6 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Participant Groups
The study tests if cognitive-behavioral therapy (CBT), exercise training, or both can reduce stress and improve mood and physical fitness in teens at risk for diabetes. It aims to see if these interventions also lower insulin resistance which is linked to developing diabetes.
4Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive-Behavioral Therapy followed by Exercise TrainingExperimental Treatment1 Intervention
6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by a 6-week exercise training intervention of 6 weekly 1-hour group sessions
Group II: Cognitive-Behavioral Therapy OnlyActive Control1 Intervention
6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by an additional 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions
Group III: Exercise Training followed by Cognitive-Behavioral TherapyActive Control1 Intervention
6-week exercise training intervention of 6 weekly 1-hour group sessions followed by a 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions
Group IV: Exercise Training OnlyActive Control1 Intervention
6-week exercise training intervention of 6 weekly 1-hour group sessions followed by an additional 6-week exercise training intervention of 6 weekly 1-hour group sessions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Colorado State UniversityFort Collins, CO
Children's Hospital ColoradoAurora, CO
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Who Is Running the Clinical Trial?
Colorado State UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
University of Colorado, DenverCollaborator
References
Indirect Effects of a Cognitive-Behavioral Intervention on Adolescent Weight and Insulin Resistance Through Decreasing Depression in a Randomized Controlled Trial. [2021]Depression is linked to excess weight, insulin resistance, and type 2 diabetes (T2D). We previously reported that in adolescent girls at-risk for T2D with moderately elevated depression, randomization to cognitive-behavioral therapy (CBT) produced greater decreases in depression at post-treament and greater decreases in fasting/2-h insulin at 1 year, compared to health education (HE). The current study is a secondary analysis of this parallel-group randomized controlled trial. We examined whether decreasing depression explained intervention effects on body composition and insulin outcomes. We hypothesized that decreases in depression would be an explanatory mediator and that indirect effects would be strongest at higher levels of baseline depression.
Coping skills training for youths with diabetes on intensive therapy. [2022]The purpose of this study was to determine if a behavioral intervention (coping skills training [CST]) combined with intensive diabetes management can improve the metabolic control and quality of life in adolescents who are implementing intensive therapy. A total of 77 youths (age range, 12.5-20 years) who were beginning intensive insulin therapy were randomly assigned to one of two groups: intensive management with CST or without CST. CST consists of a series of small group efforts designed to teach problem solving skills and communication. Data were collected preintervention and at 3 and 6 months post-intervention by using established clinical and psychosocial indicators. Randomization produced equivalent groups. After 6 months, subjects who received CST had better metabolic control (F = 3.89, p = .02) and better general self-efficacy (F = 4.54, p = 0.01). They reported less negative impact of diabetes on their quality of life (F = 4.55, p = .01) and had fewer worries about diabetes (F = 3.82, p = .02). Thus, nurses may find CST useful in assisting youths with diabetes to achieve metabolic and quality of life goals.
Prevention of insulin resistance in adolescents at risk for type 2 diabetes with depressive symptoms: 1-year follow-up of a randomized trial. [2020]Depression is associated with poor insulin sensitivity. We evaluated the long-term effects of a cognitive behavioral therapy (CBT) program for prevention of depression on insulin sensitivity in adolescents at risk for type 2 diabetes (T2D) with depressive symptoms.
Short-term effects of coping skills training as adjunct to intensive therapy in adolescents. [2022]Given the urgent need to develop effective programs that improve the ability for adolescents to achieve metabolic control equivalent to programs studied in the Diabetes. Control and Complications Trial, we have undertaken a clinical trial to determine if a behavioral intervention (coping skills training [CST]) combined with intensive diabetes management can improve metabolic control and quality of life in adolescents implementing intensive therapy regimens.
Prevention of type II diabetes by physical training. Epidemiological considerations and study methods. [2022]Disease prevention may be considered at three levels: primary (avoiding disease occurrence), secondary (early detection and reversal), and tertiary (prevention or delay of complications). Physical exercise could potentially contribute to all of these. Metabolic studies suggest the major effect of exercise is at the level of insulin sensitivity/resistance. Therefore, it may have the greatest benefit in primary prevention and in the early stages of the disease. Studies of migrants and of active and inactive professions support this notion. There is also provisional support for the benefit of exercise on metabolic control and prevention or delay of chronic complications in non-insulin-dependent (type II) diabetic patients. In designing a trial of exercise, aspects such as single/multifactorial intervention, the age range of subjects, and choice of outcome measures must be considered. The most widely used methodological tool in assessing physical activity levels in population studies is the activity questionnaire, which is nonreactive, practical, applicable, and accurate relative to other methods. A positive approach to exercise training for both the patient with type II diabetes and the general community appears to be warranted. However, trials examining the efficacy of activity intervention, with independent evaluation of both short- and long-term outcomes, are still needed.
The effectiveness of physical activity interventions for the treatment of overweight and obesity and type 2 diabetes. [2019]This review summarises current evidence relating to the effectiveness of physical activity (PA) interventions for treating overweight and obesity and type 2 diabetes. Interventions to increase PA for the treatment of overweight and obesity in both children and adults have primarily consisted of health education and behaviour modification strategies in clinical settings or with selected families or individuals. Although evidence is limited, strategies to reduce sedentary behaviours appear to have potential for reducing obesity among children and adolescents. Among adults, strategies that combine diet and PA are more effective than PA strategies alone. Combined lifestyle strategies are most successful for maintained weight loss, although most programs are unsuccessful in producing long-term changes. There is little evidence about compliance to prescribed behaviour changes or the factors that promote or hinder compliance to lifestyle changes. Limited evidence suggests that continued professional contact and self-help groups can help sustain weight loss. Most of the interventions for the treatment of type 2 diabetes have been conducted in clinical settings and have typically required the use of extensive resources. Evidence suggests that interventions can lead to small but clinically meaningful improvements in glycaemic control, even in the absence of weight loss. A recent study demonstrated that a multifactorial intervention (diet, PA and pharmaceutical) can reduce the risk of diabetes complications in individuals with type 2 diabetes. Nevertheless, there is little evidence about the effectiveness of community-based interventions in producing long-term changes in glycaemic control and reduced mortality in people with type 2 diabetes.
Physical training, lifestyle education, and coronary risk factors in obese girls. [2019]The effects of supervised physical training (PT) and lifestyle education (LSE) on risk factors for coronary artery disease and non-insulin-dependent diabetes mellitus were compared in obese 7- to 11-yr-old black girls. The subjects were divided into two groups. The PT group (N = 12) completed a 5-d.wk-1, 10-wk, aerobic training program; and the LSE group participated in weekly lifestyle discussions to improve exercise and eating habits. The PT group showed a significant increase in aerobic fitness (P
Model Programs to Address Obesity and Cardiometabolic Disease: Interventions for Suboptimal Nutrition and Sedentary Lifestyles. [2018]Problems posed by obesity-related endocrine diseases embody a national health crisis. Caloric excess and sedentary lifestyle from which they develop also pose significant challenges for rehabilitation providers. Almost two thirds of the U.S. population are currently overweight or obese, a number that has increased by >10% within the last decade and is expected to grow. An overweight body habitus is strongly associated with clinical hazards, including cardiometabolic syndrome, diabetes hypertension, and coronary artery disease. The component health risks of the cardiometabolic syndrome include coalescing of risk factors that predict a health calamity unless effective interventions can be developed and widely adopted. Obesity by itself is now considered an American Diabetes Association-qualified disability, but it is also disturbingly prevalent in other physical disability groupings of adults and children. This monograph describes successes of the Diabetes Prevention Program (DPP), a National Institutes of Health multisite randomized controlled trial that reported significant weight reduction and a 58% decreased incidence of type-2 diabetes accompanying 1 year of structured lifestyle intervention. This treatment benefit (1) exceeded that of metformin pharmacotherapy, (2) was so powerful that the trial was closed before reaching endpoints, and (3) was judged cost-effective for the patient and society. The DPP roadmap incorporating physical activity, diet, and behavioral approaches has been widely adapted to specific community, faith, racial, ethnic, school, and national populations with excellent outcomes success. The lockstep physical activity approach, activity prescription, and long-term success of the program are described and compared with other programs to illustrate effective countermeasures for the pandemics of obesity and obesity-related cardioendocrine disease. We will illustrate adaptation of the DPP for a cohort of persons with disability from spinal cord injury and the benefits observed.
Diet and exercise in type 2 diabetes mellitus. [2019]The question is no longer whether diet and exercise can benefit the individual with type 2 diabetes. Rather, the type and duration of exercise the magnitude of the effects on glycemic control, insulin sensitivity, and on risk factors for cardiovascular disease must be considered in determining the feasibility and acceptability of an intervention program. It is now clear that regular physical exercise is important in both the prevention and treatment of type 2 diabetes. The benefits of exercise are many and include increased energy expenditure, which, combined with dietary restriction, leads to decreased body fat, increased insulin sensitivity, improved long-term glycemic control, improved lipid profiles, lower blood pressure, and increased cardiovascular fitness. Persons with type 2 diabetes often find it difficult to exercise and are at increased risk for injury or exacerbation of underlying diseases or diabetic complications. Therefore, before starting an exercise program, all patients with type 2 diabetes should have a complete history and physical examination, with particular attention to evaluation of cardiovascular disease, medications that may affect glycemic control during or after exercise, and diabetic complications including retinopathy, nephropathy, and neuropathy. Exercise programs should be designed to start slowly, build up gradually, and emphasize moderately intense exercise performed at least three times a week and preferably five to seven times a week for best results.
[Prescription of physical activity in cardiology: classical and new indications (a review based on evidence based data)]. [2006]Evidence based data of physical activity in primary prevention of coronary heart disease are excellent. For secondary prevention these data still are acceptable. Although it is an important new target group for physical therapy, there are so far no favourable data for exclusive training therapy in children or adolescents presenting a syndrome of obesity, sedentary lifestyle and bad nutrition. In nearly all the studies in this field physical activity is integrated in nutrition counselling and behavioural therapy. The following recommendations for public health can be made: Each adult should exercise at least half an hour and each child or adolescent one hour a day. Physical activity is the logical response to the sedentary lifestyle and hyper caloric food intake which are continuously spreading all over the world since 3 decades. It is an excellent therapy with nearly no side effects.
Current perspectives on physical activity and exercise for youth with diabetes. [2015]Regular physical activity (PA) for youth with diabetes improves cardiorespiratory fitness, body composition, bone health, insulin sensitivity, and psychosocial well-being. However many youth with diabetes or pre-diabetes fail to meet minimum PA guidelines and a large percentage of youth with diabetes are overweight or obese. Active youth with type 1 diabetes tend to have lower HbA1c levels and reduced insulin needs, whereas activity in adolescents at-risk for type 2 diabetes improves various measures of metabolism and body composition. Insulin and nutrient adjustments for exercise in type 1 diabetes is complex because of varied responses to exercise type and because of the different times of day that exercise is performed. This review highlights the benefits of exercise and the established barriers to exercise participation in the pediatric diabetes population. A new exercise management algorithm for insulin and carbohydrate intake strategies for active youth with type 1 diabetes is presented.
A Systematic Review of Behavioral Interventions on Children at Risk for Diabetes. [2023]In adults, behavioral-based interventions support prevention of Type 2 diabetes; less is known in children. The aim of this systematic review was to examine the impact of behavioral-based interventions on cardiometabolic outcomes among children at risk for diabetes.
Cognitive-behavioral therapy and exercise training in adolescent females with elevated depression symptoms and at-risk for type 2 diabetes: Protocol for a randomized controlled trial. [2023]Adolescent-onset type 2 diabetes (T2D) is a major public health concern of growing proportions. Prevention, therefore, is critical. Unfortunately, standard-of-care treatment for T2D prevention (e.g., exercise training) show insufficient effectiveness and do not address key modifiable barriers (e.g., depression symptoms) to exercise engagement. Depression symptoms are associated with both poorer physical fitness and greater insulin resistance, the key risk factor in adolescent-onset T2D. Thus, a targeted prevention approach that addresses depression symptoms in combination with exercise training may offer a novel approach to mitigating T2D risk.
Impact of exercise on affective responses in female adolescents with type I diabetes. [2021]Adolescent is a time of profound biologic, intellectual, psychological, and socioeconomic change that they will face a crisis. Therefore, compatibility may be exposed to many hazards, such as depression, anxiety, and other emotional problems. Nevertheless, a planned regular exercise enhances physical and mental health of adolescent female with diabetes. The aim of this study was to determine the effect of exercise on emotional reactions of female adolescents with type I diabetes.