Diabetes Mellitus, Type 2ADAPTNCT03159221
Behavioral Family Systems Therapy (BFST) for Teens With Type 2 Diabetes
A study testing BFST for Teens with Type 2 Diabetes in people with Diabetes Mellitus, Type 2 and Childhood Obesity, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Childhood Obesity
- What is being tested?
- BFST for Teens with Type 2 Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2016
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
About this study
Official title: Behavioral Family Systems Therapy for Teens With Type 2 Diabetes: A Pilot
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Childhood Obesity
- Being tested
- BFST for Teens with Type 2 Diabetes
- Keywords
- type 2 diabetes in adolescents, obesity in adolescents, behavioral family systems therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFST for Teens with Type 2 DiabetesBehavioural
Also called BFST - Behavioral Family Systems Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| BFST for Teens with Type 2 Diabetes | Experimental | 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. Receives: Behavioral: BFST for Teens with Type 2 Diabetes |
| Control group (Standard Care) | No intervention | The participants assigned to the control group will receive their standard medical care for diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (weight status) at 6 months and at 12 months
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
Measured: baseline, 6 months after baseline, 12 months after baseline
Secondary outcomes (10)
metabolic control (HbA1c)
Metabolic control is measured using HbA1c values
Measured: baseline, 6 months after baseline, 12 months after baseline
Treatment Adherence
Treatment Adherence is measured using the Diabetes Self Management Survey for Teens with Type 2 Diabetes.
Measured: baseline, 6 months after baseline, 12 months after baseline
Family Problem-solving
Family problem-solving is measured using the Revised Diabetes Family Conflict Scale
Measured: baseline, 6 month after baseline
Physical activity
Physical activity is measured by an accelerometer
Measured: baseline, 6 months after baseline
Body Fat (weight status)
Body fat percent change - measured by a hand-held body fat impedance device
Measured: baseline, 6 months after baseline, 12 months after baseline
Waist Circumference (weight status)
Waist circumference in cm
Measured: baseline, 6 months after baseline, 12 months after baseline
Food intake
Nutrition/food intake as measured by the Nutrition Data Systems for Research interview
Measured: baseline, 6 months after baseline
Family communication skills
Family communication skills are measured by the Family Communication (Interaction Behavior Code)
Measured: baseline, 6 months after baseline
Teen Self-esteem
Teen Self-Perception/Self-esteem is measured by the Harter Self-Perception Profile
Measured: baseline, 6 months after baseline
Teen Quality of Life
Teen Quality of Life is measured by The Pediatric Quality of Life Inventory (PedsQL)
Measured: baseline, 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startApr 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Buckloh, PhD, Nemours Children's Clinic
- Investigators
- Lisa M Buckloh, Ph.D., Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159221
- Sponsor's protocol ID
- Buckloh
- Acronym
- ADAPT
- Status last verified
- May 2017
- First submitted
- 6 Oct 2015
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Family Systems Therapy for Teens With Type 2 Diabetes: A Pilot
- ClinicalTrials.gov ID
- NCT03159221
- Acronym / sponsor ID
- ADAPT / Buckloh
- Conditions
- Diabetes Mellitus, Type 2, Childhood Obesity
- Keywords
- type 2 diabetes in adolescents, obesity in adolescents, behavioral family systems therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 May 2017 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFST for Teens with Type 2 Diabetes | Experimental | Behavioral: BFST for Teens with Type 2 DiabetesPsychological 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. |
| Control group (Standard Care) | No intervention | –The participants assigned to the control group will receive their standard medical care for diabetes. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| BFST for Teens with Type 2 DiabetesAlso: BFST - Behavioral Family Systems TherapyBFST 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. | Behavioural | BFST for Teens with Type 2 Diabetes |
Primary outcome
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
10 secondary outcomes
metabolic control (HbA1c)
Time frame: baseline, 6 months after baseline, 12 months after baseline
Treatment Adherence
Time frame: baseline, 6 months after baseline, 12 months after baseline
Family Problem-solving
Time frame: baseline, 6 month after baseline
Physical activity
Time frame: baseline, 6 months after baseline
Body Fat (weight status)
Time frame: baseline, 6 months after baseline, 12 months after baseline
Waist Circumference (weight status)
Time frame: baseline, 6 months after baseline, 12 months after baseline
Food intake
Time frame: baseline, 6 months after baseline
Family communication skills
Time frame: baseline, 6 months after baseline
Teen Self-esteem
Time frame: baseline, 6 months after baseline
Teen Quality of Life
Time frame: baseline, 6 months after baseline
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 18 May 2017.
- 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.
Lisa M Buckloh, Ph.D. principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFST for Teens with Type 2 Diabetes in people with Diabetes Mellitus, Type 2 and Childhood Obesity, run by Nemours Children's Clinic 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 5 inclusion and 8 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 18 May 2017. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2017.