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Diabetes Mellitus, Type 2NCT04369001

Program ACTIVE: Phase 2

A study testing Community-Based Exercise and Cognitive Behavioral Therapy in people with Diabetes Mellitus, Type 2 and Depression, run by University of Michigan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The present study seeks to tailor the original Program ACTIVE (Adults Coming Together to Increase Vital Exercise) to meet the cultural norms and needs of adult Black men with comorbid Type 2 diabetes and depression by using focus groups comprised of Black men with Type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Diabetes Mellitus, Type 2, Depression
What is being tested?
Community-Based Exercise and Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2020to Dec 2021
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 18 or older
  • male sex assigned at birth
  • Black
  • a diagnosis of T2D for one year duration or longer
  • ambulatory status
  • major depression lasting 2 weeks or longer with no current evidence of psychotic symptoms. All persons scoring >5 on a PHQ-9 administered via a telephone screening (administered by a research assistant or project coordinator) will be invited to participate. Patients who are currently prescribed antidepressant medications for 6 weeks or longer and who meet diagnostic criteria for major depression without psychotic features will be included. Patients who are currently receiving only medication management from a psychiatrist will be included. Respondents who meet eligibility criteria will be invited to participate in the baseline screening assessment.

Who cannot join

  • Stage 2 hypertension as defined by JNC VIII
  • recent cardiac events
  • recent laser surgery for proliferative retinopathy
  • history of stroke
  • lower limb amputation
  • asensory peripheral neuropathy
Show all 11Show fewer
  • aortic stenosis or other severe valvular heart disease
  • atrial fibrillation
  • severe COPD (e.g., basal oxygen)
  • class III or IV heart failure or medical instability
  • Patients who report the use of a current antidepressant medication for 5 weeks or less will be excluded or deferred for later screening after the 6-week period. Patients who are currently receiving psychotherapy services from a mental health provider will be excluded. Psychiatric exclusion criteria include: active suicidal ideation or a history of a suicide attempt, bipolar depression or history of psychotic disorder, current substance use or dependent disorder.

About this study

Official title: Program ACTIVE: Implementing a Cognitive Behavioral Therapy and Physical Activity Program for Black Men With Comorbid Diabetes and Depression

The present study seeks to tailor the original Program ACTIVE (Adults Coming Together to Increase Vital Exercise) to meet the cultural norms and needs of adult Black men with comorbid Type 2 diabetes and depression by using focus groups comprised of Black men with Type 2 diabetes. The use of peer perspectives allows for an improved strategy to reach, retain, and improve outcomes in this population.

Following the tailoring of program materials, the intervention (Program ACTIVE) will be facilitated with Black men with comorbid Type 2 diabetes and depression using evidence-based cognitive behavioral therapy and community-based exercise interventions.

Read the detailed description

Black men have a 1.5 higher incidence of type 2 diabetes (T2D) compared to non-Hispanic White men and are twice as likely to die from diabetes-related complications. Additionally, Black men are more likely to be diagnosed with T2D compared to non-Hispanic White men, and this disparity increases among men over the age of 55. Poor diabetes self-management dramatically increases the risk for micro and macrovascular complications. Because Black men have worsened glycemic management compared to non-Hispanic White men, their risk for these diabetes complications is higher. In addition to physical complications, patients with T2D are twice as likely to experience depressive symptoms than those without T2D. Depressive symptoms are associated with suboptimal blood glucose levels and diabetes complications. A growing body of literature also demonstrates the critical role of gender in the management of physical and mental health conditions, including T2D and depression, and shows that male gender norms may conflict with help-seeking and healthy behaviors.

Program ACTIVE (Adults Coming Together to Increase Vital Exercise) is an evidence-based, cognitive behavioral therapy (CBT) and community-based exercise (EXER) intervention that aims to improve diabetes and depression outcomes that was developed for adults with type 2 diabetes. Research suggests that Black men have more adverse life experiences than men of other racial/ethnic groups, and consequently, experience worsened mental health. Since CBT and exercise programs are the gold standard for treating comorbid T2D and depression, tailoring these existing interventions to meet the needs of Black men with T2D is critical, especially given that high rates of T2D and depression exist in low income Black communities. Additionally, there is a dearth of literature about barriers and facilitators to mental health care utilization and exercise among Black men with T2D. The proposed study seeks to:

Aim 1 (Pre-implementation): Adapt an evidence-based intervention to work with Black men with T2D and depression in a community-based clinic. Adaptation and refinement, guided by the TDF domains, will involve:

  1. conducting focus groups with Black men with comorbid T2D and depression to assess barriers and facilitators to mental health care utilization and exercise and to evaluate feasibility and acceptability of intervention materials.

Aim 2: Assess the impact of the implementation intervention strategies developed in Aim 1 by:

  1. conducting a pilot randomized controlled trial of Program ACTIVE to evaluate participant recruitment and retention rates, treatment and intervention satisfaction and estimate intervention effect sizes on our primary outcomes of glycemic control (HbA1c) and depression as well as on secondary outcomes such as self-management behaviors and diabetes social support at baseline, 3 and 6 months post-intervention. Data from the pilot trial will help refine recruitment strategies, training materials, and the implementation protocol to be used in a larger pilot trial.
  2. conducting qualitative interviews, guided by the TDF domains, to better understand the acceptability and sustainability of M-Action as routine practice in a community-based clinic.
Being tested
Community-Based Exercise, Cognitive Behavioral Therapy
Keywords
Type 2 diabetes, Depression
Medical subject headings
Diabetes Mellitus, Type 2, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-Based ExerciseBehavioural

    Also called EXER

    Participants will complete 150 minutes of exercise per week for 12 weeks. Exercise per week will be documented using exercise logs. The exercise protocol will be a culturally-tailored community-based exercise intervention based on the aerobic exercise goals used in the Program ACTIVE study and psychoeducational materials adapted from Program ACTIVE based on feedback from Black men with T2D. Exercise in Program ACTIVE will be obtained through individualized community-based activities that participants in the focus groups indicate as feasible rather than the highly controlled laboratory environment. Exercise goals will be adapted to accommodate the physical and medical restrictions of an older-adult diabetes population.

  • Cognitive Behavioral TherapyBehavioural

    Also called CBT

    Participants will receive 10 sessions of CBT using a manualized approach based on Beck's model of cognitive therapy. Sessions are to be completed once weekly in conjunction with weekly exercise. The Program ACTIVE CBT intervention includes: presentation of CBT model; thought records, cognitive distortions, counterarguments, cognitive reframing, automatic thoughts, core beliefs, and relapse prevention. Session goals will be tailored to the needs of men so that the order of topics may vary. Each session will begin with the designation of session goals, review of previously assigned homework, and introduction of new concepts and skills. Individually-tailored homework assignments designed to provide practice with the concepts/skills of the session will be assigned.

Study groups in NCT04369001
Study groupRoleWhat they receive
Intervention GroupExperimental(Program ACTIVE n=20) Participants randomized into the Program ACTIVE group will receive a gym membership to a local, Detroit-based community recreation facility where they will complete 150 minutes of exercise per week for 12 weeks and will receive 10 sessions (once weekly) of CBT therapy sessions. Exercise per week will be documented using exercise logs. Exercise logs will be given to research staff at the end of the 12-week timeframe; all exercise logs will be kept organized respective to the participant identification number and related documents (questionnaires and surveys). To ensure treatment fidelity, three CBT and three physical activity sessions will be selected at random and recorded and rated for fidelity to the above content by our research team.
Receives: Behavioral: Community-Based Exercise; Behavioral: Cognitive Behavioral Therapy
Enhanced Usual CareNo intervention(EUC n=20) Participants randomized to enhanced usual care will receive referrals to community mental health providers, pedometers, gym memberships to a community-based venue, and intervention patient manuals. Participants will not be required to report any use of resources offered or change their course of treatment in any way. Based on several years of experience in Detroit, providing all participants with referrals, pedometers, gym access and educational materials minimizes ethical concerns regarding assignment of underserved populations to receive a no-treatment control.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Metabolic Control

    Metabolic Control will be measured via hemoglobin A1c (HbA1c). HbA1c will be collected using the DCA 2000 point-of-care testing instrument.

    Measured: HbA1c will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post treatment assessment.

  2. Change of Depression Scores

    Depression will be measured using the PHQ-9 (score >=10) and The BDI-II, a 21-item self-administered questionnaire used to assess symptoms of depression. Depression will be measured using the Beck Depression Inventory (BDI-II). BDI-II items have been designed to correspond with DSM-IVTR diagnostic criteria. The BDI-II has been shown to have excellent test-retest reliability and validity when used in general populations as well for use with diabetes samples.

    Measured: Depression scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

Secondary outcomes (8)

  1. Change of Regimen Adherence

    Regimen adherence will be measured using the Perceived Diabetes Self-Management Scale, a self-report questionnaire used to measure a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. The responses for the PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." Four of the items (#s 1, 2, 6, \& 7) are worded such that high agreement signifies low self-efficacy or perceived competence. These four items are reverse scored prior to being added to the other four items. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.

    Measured: Perceived Diabetes Self-Management scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

  2. Change of Adherence to Gender Norms

    Adherence to gender norms will be measured using the Male Role Norms Inventory-Short Form. The items are separated into seven subscales: Restrictive Emotionality, Self-Reliance Through Mechanical Skills, Negativity Toward Sexual Minorities, Avoidance of Femininity, Importance of Sex, Toughness, and Dominance. Response Options are on a 7-point scale ranging from strongly disagree = 1 to strongly agree = 7. Higher scores indicate more traditional gender role beliefs.

    Measured: Male Role Norms Inventory-Short Form scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

  3. Change of Body Mass Index

    Body Mass Index will be calculated using height and weight. Height will be measured using a stadiometer.

    Measured: Body Mass Index will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

  4. Change of Weight

    Weight will be measured on a high quality, calibrated digital scale.

    Measured: Weight will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

  5. Change of Blood Pressure

    Blood Pressure will be measured using the auscultatory method assessing for both diastolic and systolic pressure.

    Measured: Blood Pressure will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

  6. Change of Diabetes Social Support

    Diabetes Social Support will be measured using the Diabetes Social Support Questionnaire. The questionnaire is a 5-item survey with answers ranging from 1 - "I receive none" to 5 - "I don't need help." Total scores range from a minimum of 5, indicating low social support for diabetes treatment and management, to 25, a high indication of social support for diabetes treatment and management.

    Measured: Diabetes Social Support scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

  7. Change of Diabetes-Related Distress

    Diabetes-related Distress will be measured using Diabetes Distress Scale (Short Form-12). The Diabetes Distress Scale items pertain to common emotions perceived by individuals self-managing their diabetes. The scale, ranging from 1 = not a problem to 6 = very serious problem scores the degree to which the items have distressed the individual.

    Measured: Diabetes Related Distress scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

  8. Change of Diabetes Quality of Life

    Diabetes Quality of Life will be used to measure quality of life. The DQoL measure consists of 46 items ranked on a 5-point Likert scale. Total scores range from 0 (lowest possible QoL) to 100 (highest possible QoL).

    Measured: Diabetes Quality of Life scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: Due to covid-19 and social distancing, this study was terminated.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04369001
Sponsor's protocol ID
ProgramACTIVE
Other IDs
P30DK092926
Status last verified
Jan 2021
First submitted
14 Apr 2020
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Centers for Disease Control and Prevention. Age-Adjusted Percentage of Civilian, Noninstitutionalized Population with Diagnosed Diabetes, by Race and Sex, United States, 1980-2011, 2013. http://www.cdc.gov/diabetes/statistics/prev/national/figraceethsex.htm

  • Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services, 2014.

  • Egede LE, Mueller M, Echols CL, Gebregziabher M. Longitudinal differences in glycemic control by race/ethnicity among veterans with type 2 diabetes. Med Care. 2010 Jun;48(6):527-33. doi: 10.1097/MLR.0b013e3181d558dc.

    PubMed 20473215

  • Liburd LC, Namageyo-Funa A, Jack L Jr. Understanding "masculinity" and the challenges of managing type-2 diabetes among African-American men. J Natl Med Assoc. 2007 May;99(5):550-2, 554-8.

    PubMed 17534013

  • Seawell AH, Hurt TR, Shirley MC. The Influence of Stress, Gender, and Culture on Type 2 Diabetes Prevention and Management Among Black Men: A Qualitative Analysis. Am J Mens Health. 2016 Mar;10(2):149-56. doi: 10.1177/1557988315580132. Epub 2015 Apr 9.

    PubMed 25862692

  • Hawkins, J, Kieffer EC, Sinco B et al.

  • Hawkins J, Watkins DC, Kieffer E, Spencer M, Piatt G, Nicklett EJ, Lebron A, Espitia N, Palmisano G. An Exploratory Study of the Impact of Gender on Health Behavior Among African American and Latino Men With Type 2 Diabetes. Am J Mens Health. 2017 Mar;11(2):344-356. doi: 10.1177/1557988316681125. Epub 2016 Dec 5.

    PubMed 27923970

  • de Groot M, Doyle T, Kushnick M, Shubrook J, Merrill J, Rabideau E, Schwartz F. Can lifestyle interventions do more than reduce diabetes risk? Treating depression in adults with type 2 diabetes with exercise and cognitive behavioral therapy. Curr Diab Rep. 2012 Apr;12(2):157-66. doi: 10.1007/s11892-012-0261-z.

    PubMed 22350739

  • Holden KB, McGregor BS, Blanks SH, Mahaffey C. Psychosocial, socio-cultural, and environmental influences on mental health help-seeking among African-American men. J Mens Health. 2012 Jun 1;9(2):63-69. doi: 10.1016/j.jomh.2012.03.002.

    PubMed 22905076

  • Watkins DC, Hawkins J, Mitchell JA. The Discipline's Escalating Whisper: Social Work and Black Men's Mental Health. Res Soc Work Pract. 2015 Mar;25(2):240-250. doi: 10.1177/1049731514526621. Epub 2014 Mar 19.

    PubMed 31289430

  • Watkins DC, Jefferson SO. Recommendations for the use of online social support for African American men. Psychol Serv. 2013 Aug;10(3):323-32. doi: 10.1037/a0027904. Epub 2012 Aug 27.

    PubMed 22924797

  • Watkins DC. Depression over the adult life course for African American men: toward a framework for research and practice. Am J Mens Health. 2012 May;6(3):194-210. doi: 10.1177/1557988311424072. Epub 2011 Nov 21.

    PubMed 22105067

  • Williams DR. The health of men: structured inequalities and opportunities. Am J Public Health. 2003 May;93(5):724-31. doi: 10.2105/ajph.93.5.724.

    PubMed 12721133

  • Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.

    PubMed 22530986

  • Michigan Department of Community Health. Michigan Primary Care Transformation Project (MIPCT): Information for Michigan POs/PHOs and Payers 2011.

Questions about this trial

What is this clinical trial studying?

A study testing Community-Based Exercise and Cognitive Behavioral Therapy in people with Diabetes Mellitus, Type 2 and Depression, run by University of Michigan.

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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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 of Metabolic Control (time frame: HbA1c will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post treatment assessment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04369001, which also lists 40 linked publications.

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 25 Jan 2021.

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Program ACTIVE: Phase 2 (NCT04369001) | AzTrials