Call-2-Health: Preventing Type II Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— C2H  

Official title:

Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827826
• Other study ID #: 184802-16
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: October 11, 2017
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Telephonic intervention to prevent Diabetes Mellitus, Type 2
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.

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program feasibility: Uptake	Measured by the number of people who consent to be in the study compared to the number who were eligible	Baseline
Primary	Program feasibility: Attendance	Measured by the number of participants who return for their 12 week clinic visit	12 weeks
Primary	Program feasibility: Attendance	Measured by the number of participants who return for their 24 week clinic visit	24 weeks
Primary	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	Fasting glucose	Measured via a fasting blood draw	Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	Waist circumference	in centimeters	Baseline, 12 weeks, 24 weeks
Secondary	Blood pressure	Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)	Baseline, 12 weeks, 24 weeks
Secondary	Healthy eating habits	Assessed using the Food Frequency Questionnaire	Baseline, 12 weeks, 24 weeks
Secondary	Weight loss	Weight measured in kilograms	Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	Changes in activity	Measured using the Modifiable Activity Questionnaire (MAQ)	Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	Glycated hemoglobin (A1C)	Measured via a fasting blood draw	Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	Total cholesterol (TC)	Measured via a fasting blood draw	Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	High density lipoprotein (HDL)	Measured via a fasting blood draw	Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	Low density lipoprotein (LDL)	Measured via fasting blood draw.	Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	Body Mass Index (BMI)		Baseline, 12 weeks, 24 weeks, 52 weeks
Secondary	Physical activity level	Participants wore a blinded pedometer for 3 days	Baseline, 12 weeks, 24 weeks, 52 weeks