Call-2-Health: Preventing Type II Diabetes

NCT01827826 | Completed DMC

• 1 other identifier: 184802-16
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks. For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss

Conditions

Diabetes Mellitus, Type 2

Keywords

Intervention; Telephone; Diabetes; Prevention

Outcome Measures

Primary Outcomes (4)

• Program feasibility: Uptake

  Measured by the number of people who consent to be in the study compared to the number who were eligible

  Baseline

• Program feasibility: Attendance

  Measured by the number of participants who return for their 12 week clinic visit

  12 weeks

• Program feasibility: Attendance

  Measured by the number of participants who return for their 24 week clinic visit

  24 weeks

• Program feasibility: Attendance

  Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)

  52 weeks

Secondary Outcomes (12)

• Fasting glucose

  Baseline, 12 weeks, 24 weeks, 52 weeks

• Waist circumference

  Baseline, 12 weeks, 24 weeks

• Blood pressure

  Baseline, 12 weeks, 24 weeks

• Healthy eating habits

  Baseline, 12 weeks, 24 weeks

• Weight loss

  Baseline, 12 weeks, 24 weeks, 52 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants assigned to the intervention group worked with the study interventionist over the phone to reduce their risk for developing Diabetes Mellitus, Type 2. The intervention lasted for 24 weeks, with weekly phone calls for the first 12 weeks and 4 maintenance calls over the second 12 weeks. Study measurements were taken at baseline, 12 weeks, 24 weeks, and 52 weeks. After 24 weeks, the investigators randomly divided the intervention group in half. The first group did not receive any more phone calls from the interventionist. The second group continued to receive monthly 20-minute phone calls from the interventionist. At 52 weeks post-baseline participants from both groups had their labs drawn, wore a pedometer for 3 days, and called in with a self-reported weight.

Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2

Control

NO INTERVENTION

Participants randomized into this group did not receive any intervention, although they were encouraged to follow-up with their doctor and follow through with usual clinical care.

Interventions

Telephonic intervention to prevent Diabetes Mellitus, Type 2 BEHAVIORAL

Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks. The first 12 weeks was the intervention phase and calls were made weekly. The second 12 weeks was the maintenance phase and calls were made every 3 weeks. After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls. The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.

Intervention

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age 40-74
• Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
• Can walk for more than 10 minutes
• Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
• Body Mass Index (BMI) 25 kg/m2 or greater

You may not qualify if:

• Type 1 or 2 diabetes
• FPG \> 125 mg/dl or \< 105mg/dl at screening blood draw
• HbA1C \> 6.4 or \< 5.7 at screening blood draw
• Systolic blood pressure \> 210 mmHg at the baseline clinic visit
• Exercise ≥ 30 minutes/day, at least five days a week
• Current participation in another structured weight loss treatment program or another intervention study
• Severe concurrent disease
• Unavailable for the 24-week study period
• Unable to read or speak English
• Pregnant or planning to become pregnant.
• Mentally or legally incapacitated such that informed consent cannot be obtained.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Katherine Newton, PhD

  Group Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: April 10, 2013
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: June 1, 2012
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

US (1)