Ignite Creation Date:
2024-05-06 @ 3:35 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02320253
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2014-12-10
Brief Title:
REAL HEALTH-Diabetes Reach Ahead for Lifestyle and Health-Diabetes
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
REAL HEALTH-Diabetes Reach Ahead for Lifestyle and Health-Diabetes
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for type 2 diabetes and obesity into usual care at community health centers comparing an in-person group program IP a telephone conference call TCC group program and referral to medical nutrition therapy MNT the current standard of care
Detailed Description:
Participants will be randomly assigned to one of three arms MNT IP or TCC Participants will be enrolled in the study for a total of three years During those three years participants will have 5 research visits at baseline where randomization occurs 6 months 12 months 24 months and 36 months At each research visit participants will have a lipid panel and HbA1c sample drawn their blood pressure weight and height baseline only taken Participants will also answer questionnaires that will address health behaviors self-efficacy measures of self-determination depression literacy and numeracy food insecurity health-related quality-of-life and patient satisfaction with quality of care
For the group-based interventions dietitians will deliver the adapted Look AHEAD lifestyle intervention The first 14 sessions will be delivered weekly and the next 5 sessions biweekly In the subsequent 18 months group sessions will be delivered monthly from 6-24 months In addition participants will be offered up to 5 individual MNT sessions over the 2 year intervention period At these individual visits dietitians will address diabetes-related issues and discuss tailored goals and behaviors based on the Look AHEAD model Dietitians will provide ongoing feedback to participants own PCPs about patient progress toward goals and will encourage PCPs to reinforce weight loss strategies with their patients Each group will contain up to 12 participants with type 2 diabetes and will last 1-15 hours The program curriculum focuses on nutrition activity and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success
In addition to the teaching component participants who are taking insulin or medications that can cause hypoglycemia will self-monitor blood glucose levels at least 2 times per day and submit self-monitoring records for review each week either by delivering them at the in-person sessions or by mailing faxing or emailing them to the study team Patients on oral hypoglycemics who are not adjusting medications based on blood sugar will be instructed to do targeted monitoring to determine the effects of exercise and meals on blood glucose The study provider at each health center will review BG records and make any needed adjustments to insulin or medication doses according to an algorithm to maintain glycemic control and prevent hypoglycemia as participants lose weight
A trained member of the study staff will provide MNT referral participants with an educational handout emphasizing that modest weight loss 5 - 10 via caloric restriction and gradual adoption of moderate increases in daily physical activity equivalent to brisk walking for 30 minutes daily is safe and effective in managing diabetes and schedule them for an appointment with a dietitian from Nutrition Services for follow up
For the group-based interventions dietitians will deliver the adapted Look AHEAD lifestyle intervention The first 14 sessions will be delivered weekly and the next 5 sessions biweekly In the subsequent 18 months group sessions will be delivered monthly from 6-24 months In addition participants will be offered up to 5 individual MNT sessions over the 2 year intervention period At these individual visits dietitians will address diabetes-related issues and discuss tailored goals and behaviors based on the Look AHEAD model Dietitians will provide ongoing feedback to participants own PCPs about patient progress toward goals and will encourage PCPs to reinforce weight loss strategies with their patients Each group will contain up to 12 participants with type 2 diabetes and will last 1-15 hours The program curriculum focuses on nutrition activity and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success
In addition to the teaching component participants who are taking insulin or medications that can cause hypoglycemia will self-monitor blood glucose levels at least 2 times per day and submit self-monitoring records for review each week either by delivering them at the in-person sessions or by mailing faxing or emailing them to the study team Patients on oral hypoglycemics who are not adjusting medications based on blood sugar will be instructed to do targeted monitoring to determine the effects of exercise and meals on blood glucose The study provider at each health center will review BG records and make any needed adjustments to insulin or medication doses according to an algorithm to maintain glycemic control and prevent hypoglycemia as participants lose weight
A trained member of the study staff will provide MNT referral participants with an educational handout emphasizing that modest weight loss 5 - 10 via caloric restriction and gradual adoption of moderate increases in daily physical activity equivalent to brisk walking for 30 minutes daily is safe and effective in managing diabetes and schedule them for an appointment with a dietitian from Nutrition Services for follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R18DK102737-01A1 | NIH | None | httpsreporternihgovquickSearch1R18DK102737-01A1 |