Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics

Conditions

Diabetes, Obesity, Pre-diabetes

Keywords

behavior change, pre-diabetes, prevention, diabetes prevention, Hemoglobin A1c, glucose, physical activity, nutrition, email, web, obesity

Brief summary

The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.

Sherry Pagoto, Bengisu Tulu, Molly E. Waring, Jared M. Goetz, Jessica Bibeau et al. (8 authors)

JMIR mhealth and uhealth2021-04-0124 citations

10.2196/24249

Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes

Gladys Block, Kristen MJ Azar, Robert J. Romanelli, Torin Block, Donald R. Hopkins et al. (10 authors)

Journal of Medical Internet Research2015-10-23276 citations

10.2196/jmir.4897

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

Gladys Block, Kristen MJ Azar, Torin Block, Robert J. Romanelli, Heather A Carpenter et al. (8 authors)

JMIR Research Protocols2015-01-2128 citations

10.2196/resprot.4046

Interventions

BEHAVIORALAlive-PD

Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support

BEHAVIORALUsual Care

Placebo Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 79 Years

Healthy volunteers

No

Inclusion criteria

* at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance * at least one measurement of body mass index (BMI) \>=27 in the past two years * age 40-79 * no use of diabetes medications within the past two years * member of Kaiser Permanente of Northern California (KPNC) for at least 2 years * live in a 25 mile radius of the KPNC Research Clinic in Oakland, CA

Exclusion criteria

* comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in body weight	at 3 months, 6 months and one year	Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months
Change from baseline in diabetes risk markers	at 3 months, 6 months and one year	Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months

Secondary

Measure	Time frame	Description
Change from baseline in physical activity and dietary factors	3 months and 12 months	Extent of change in physical activity and dietary factors as reported in questionnaires

Countries

United States

Outcome results

None listed