Diabetes Mellitus, Type 2C2HNCT01827826
Call-2-Health: Preventing Type II Diabetes
A study testing Telephonic intervention to prevent Diabetes Mellitus, Type 2 in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Telephonic intervention to prevent Diabetes Mellitus, Type 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
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
- Being tested
- Telephonic intervention to prevent Diabetes Mellitus, Type 2
- Keywords
- Intervention, Telephone, Diabetes, Prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic intervention to prevent Diabetes Mellitus, Type 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program feasibility: Uptake
Measured by the number of people who consent to be in the study compared to the number who were eligible
Measured: Baseline
Program feasibility: Attendance
Measured by the number of participants who return for their 12 week clinic visit
Measured: 12 weeks
Program feasibility: Attendance
Measured by the number of participants who return for their 24 week clinic visit
Measured: 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)
Measured: 52 weeks
Secondary outcomes (12)
Fasting glucose
Measured via a fasting blood draw
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Waist circumference
in centimeters
Measured: Baseline, 12 weeks, 24 weeks
Blood pressure
Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
Measured: Baseline, 12 weeks, 24 weeks
Healthy eating habits
Assessed using the Food Frequency Questionnaire
Measured: Baseline, 12 weeks, 24 weeks
Weight loss
Weight measured in kilograms
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Changes in activity
Measured using the Modifiable Activity Questionnaire (MAQ)
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Glycated hemoglobin (A1C)
Measured via a fasting blood draw
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Total cholesterol (TC)
Measured via a fasting blood draw
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
High density lipoprotein (HDL)
Measured via a fasting blood draw
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Low density lipoprotein (LDL)
Measured via fasting blood draw.
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Body Mass Index (BMI)
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Physical activity level
Participants wore a blinded pedometer for 3 days
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJul 2010
- Primary completionOct 2011
- Study completionJun 2012
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.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Newton, PhD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827826
- Sponsor's protocol ID
- 184802-16
- Acronym
- C2H
- Status last verified
- Oct 2017
- First submitted
- 11 Sep 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
- ClinicalTrials.gov ID
- NCT01827826
- Acronym / sponsor ID
- C2H / 184802-16
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Intervention, Telephone, Diabetes, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Apr 2013 (estimated)
- 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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Telephonic intervention to prevent Diabetes Mellitus, Type 2Participants 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. |
| 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. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Telephonic intervention to prevent Diabetes Mellitus, Type 2Participants 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. | Behavioural | Intervention |
Primary outcome
Program feasibility: Uptake
Time frame: Baseline
Measured by the number of people who consent to be in the study compared to the number who were eligible
Program feasibility: Attendance
Time frame: 12 weeks
Measured by the number of participants who return for their 12 week clinic visit
Program feasibility: Attendance
Time frame: 24 weeks
Measured by the number of participants who return for their 24 week clinic visit
Program feasibility: Attendance
Time frame: 52 weeks
Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
12 secondary outcomes
Fasting glucose
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Waist circumference
Time frame: Baseline, 12 weeks, 24 weeks
Blood pressure
Time frame: Baseline, 12 weeks, 24 weeks
Healthy eating habits
Time frame: Baseline, 12 weeks, 24 weeks
Weight loss
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Changes in activity
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Glycated hemoglobin (A1C)
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Total cholesterol (TC)
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
High density lipoprotein (HDL)
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Low density lipoprotein (LDL)
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Body Mass Index (BMI)
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Physical activity level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
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 13 Oct 2017.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Katherine Newton, PhD principal investigator
Group Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephonic intervention to prevent Diabetes Mellitus, Type 2 in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente 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 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: finished, as of the sponsor's last update on 13 Oct 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?
Program feasibility: Uptake (time frame: Baseline). The study lists 4 primary outcomes in all. 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 13 Oct 2017.