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Trial record 4 of 7689 for:    Type 2 Diabetes

Behavioral Family Systems Therapy (BFST) for Teens With Type 2 Diabetes (ADAPT)

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ClinicalTrials.gov Identifier: NCT03159221
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Lisa Buckloh, PhD, Nemours Children's Clinic

Brief Summary:
This is a randomized, controlled pilot trial of Behavioral Family Systems Therapy for Teens with Type 2 Diabetes (BFST-DM2), an individual psychological intervention tailored to meet the needs of teens with type 2 diabetes. It is hypothesized that this behavioral family intervention will be feasible to implement with teens with type 2 diabetes and will have positive effects on treatment adherence, health outcomes like weight status and metabolic control, and psychological outcomes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Childhood Obesity Behavioral: BFST for Teens with Type 2 Diabetes Not Applicable

Detailed Description:
The incidence of type 2 diabetes mellitus (DM2) in youth is increasing dramatically with the rise in obesity in the U.S. and worldwide. DM2 in youth, as with adults, is clearly linked to modifiable risk factors such as obesity, sedentary lifestyle, and poor diet. Youth with DM2 are at increased risk for medical complications such as cardiovascular disease, retinopathy, and neuropathy, as well as psychological problems such as depression, anxiety, poor self-esteem, eating disorders, and poor coping and problem solving. Although there are studies demonstrating that family-based lifestyle and psychological interventions are successful in reducing obesity in youth and in improving metabolic control and adherence in youth with type 1 diabetes mellitus (DM1), very little has been published on potential lifestyle or psychological treatments for youth with DM2. Studies have shown that Behavioral Family Systems Therapy (BFST) has been effective in improving metabolic control, adherence, family communication, and problem solving in youth with DM1. This intervention could be effective in treating youth with DM2, as many of the skills necessary for good metabolic control, health outcomes, treatment adherence, and psychological adjustment are similar in both populations. This application proposes a randomized, controlled pilot trial of BFST-DM2, an individual psychological intervention tailored to meet the needs of teens with DM2. BFST will be adapted to make this intervention more feasible and relevant with minority and low-income populations and also to focus on weight management, exercise, and nutrition. The BFST-DM2 intervention includes 12 (90-minute) sessions over 6 months. Areas targeted for improvement will include metabolic control, weight/body mass index, treatment adherence, family lifestyle choices (activity, diet), family communication, and problem solving. One of the main aims of this pilot study is to gather exploratory information on the effectiveness of the BFST-DM2 intervention on measures of health outcomes, medical adherence, lifestyle changes, and family problem-solving and communication skills. In addition, it is an aim to estimate treatment effect size to determine the sample size needed to power a larger multi-site trial of the BFST-DM2 intervention. Other aims include determining factors associated with feasibility (recruitment, retention, participation, generalizability) as well as to modify the intervention to be culturally sensitive and to be more relevant to the individual needs of the DM2 adolescent population. The BFST-DM2 intervention will be compared with standard medical therapy on measures of health outcomes (metabolic control, body mass index, weight, waist circumference, body fat) physical activity (accelerometer), nutritional intake, treatment adherence, psychological adjustment (self-esteem, quality of life), family communication, and problem solving. The researchers will analyze predictors of treatment outcome and the treatment effects at the immediate post-treatment interval (6 months from baseline). Health outcomes and medical adherence data also will be collected 12 months from baseline to determine maintenance of treatment effects over time.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Family Systems Therapy for Teens With Type 2 Diabetes: A Pilot
Study Start Date : April 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: BFST for Teens with Type 2 Diabetes
Psychological intervention: Families randomized to the intervention group will receive 12 sessions of Behavioral Family Systems Therapy for Teens with type 2 diabetes (BFST-DM2) over 6 months.
Behavioral: BFST for Teens with Type 2 Diabetes
BFST for Teens with Type 2 Diabetes: 12 (90 minute sessions) over 6 months of Behavioral Family Systems Therapy (BFST), delivered by a Licensed clinical social worker. BFST consists of 4 components: problem-solving, communication skills training, cognitive restructuring, and functional and structural family therapy.
Other Name: BFST - Behavioral Family Systems Therapy
No Intervention: Control group (Standard Care)
The participants assigned to the control group will receive their standard medical care for diabetes.



Primary Outcome Measures :
  1. Change in Body Mass Index (weight status) at 6 months and at 12 months [ Time Frame: baseline, 6 months after baseline, 12 months after baseline ]
    Body Mass Index (adjusted for height, gender, and age) - height and weight in kg and meters (kg/m^2) - change in BMI across time points is being studied - change in weight from baseline to 6 months and change in weight from baseline to 12 months


Secondary Outcome Measures :
  1. metabolic control (HbA1c) [ Time Frame: baseline, 6 months after baseline, 12 months after baseline ]
    Metabolic control is measured using HbA1c values

  2. Treatment Adherence [ Time Frame: baseline, 6 months after baseline, 12 months after baseline ]
    Treatment Adherence is measured using the Diabetes Self Management Survey for Teens with Type 2 Diabetes.

  3. Family Problem-solving [ Time Frame: baseline, 6 month after baseline ]
    Family problem-solving is measured using the Revised Diabetes Family Conflict Scale

  4. Physical activity [ Time Frame: baseline, 6 months after baseline ]
    Physical activity is measured by an accelerometer

  5. Body Fat (weight status) [ Time Frame: baseline, 6 months after baseline, 12 months after baseline ]
    Body fat percent change - measured by a hand-held body fat impedance device

  6. Waist Circumference (weight status) [ Time Frame: baseline, 6 months after baseline, 12 months after baseline ]
    Waist circumference in cm

  7. Food intake [ Time Frame: baseline, 6 months after baseline ]
    Nutrition/food intake as measured by the Nutrition Data Systems for Research interview

  8. Family communication skills [ Time Frame: baseline, 6 months after baseline ]
    Family communication skills are measured by the Family Communication (Interaction Behavior Code)

  9. Teen Self-esteem [ Time Frame: baseline, 6 months after baseline ]
    Teen Self-Perception/Self-esteem is measured by the Harter Self-Perception Profile

  10. Teen Quality of Life [ Time Frame: baseline, 6 months after baseline ]
    Teen Quality of Life is measured by The Pediatric Quality of Life Inventory (PedsQL)



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus for 6 months or more
  • Age-adjusted Body Mass Index at or above the 85th percentile (considered overweight)
  • Established diabetes care in Nemours Children's Clinic system or diabetes care meets minimum criteria for current American Diabetes Association Standards.
  • Adolescent lives at home in the study geographical area (Jacksonville, FL)over the course of the study duration (one year).
  • One caregiver in the home is willing to participate in the family intervention.

Exclusion Criteria:

  • Adolescent has another systemic chronic disease other than well-controlled asthma.
  • Genetic syndrome or disorder (other than diabetes) known to affect glucose tolerance.
  • Daily use of glucocorticoids or other medications known to affect glucose tolerance.
  • Teen is enrolled in special education for students who have autism or are mentally handicapped.
  • Adolescent is pregnant or planning to be pregnant within 1 year.
  • Teen resides in temporary foster care, group home, or juvenile detention center.
  • The family has an open case with an agency investigating child abuse or neglect.
  • Adolescent has been in an inpatient psychiatric facility or substance abuse treatment in the past 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159221


Locations
United States, Florida
Nemours Children's Specialty Care
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Lisa M Buckloh, Ph.D. Nemours Children's Clinic

Responsible Party: Lisa Buckloh, PhD, Clinical Research Psychologist, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03159221     History of Changes
Other Study ID Numbers: Buckloh
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lisa Buckloh, PhD, Nemours Children's Clinic:
type 2 diabetes in adolescents
obesity in adolescents
behavioral family systems therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms