NEW DAY: Nutrition, Exercise, Weight Loss, Diabetes And You

Obesity Treatment and NIDDM in Black and White Women

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00007800

Enrollment

218

Registered

2001-01-05

Start date

2000-05-31

Completion date

2002-05-31

Last updated

2010-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Obesity

Keywords

obesity treatment, non insulin dependent diabetes, type 2 diabetes, behavioral weight control, motivational interviewing, motivational enhancement

Brief summary

This clinical trial examines whether the addition of individual sessions of a motivational intervention to a state-of-the art behavioral group weight loss intervention for overweight women with Type 2 diabetes improves the weight losses and glycemic control outcomes.

Detailed description

The multi-disciplinary behavioral, group-based intervention focuses on dietary and exercise changes, with group meetings over an 18-month period. Participants are assessed at 6-month intervals (for a total of 18 months) to examine the impact of the interventions on body weight and blood sugar control (primary outcomes), as well as on blood pressure, cholesterol, quality of life and attitudes (secondary outcomes). All enrolled participants receive group-based weight loss intervention. Half the women enrolled also receive several individual sessions of motivational interviewing and the other half of enrolled women receive the same number of individual sessions of health education, which focus on issues relevant to women (e.g., mammography, sleep hygiene, menopause, etc).

Interventions

BEHAVIORALBehavioral Group Weight Loss Intervention

BEHAVIORALMotivational Interviewing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Body Mass Index of 27 - 50 * Type 2 diabetes currently treated with oral medications * Ability to walk for exercise

Exclusion criteria

* Use of insulin * Current pregnancy * Presence of debilitating disease, psychotic condition or any other condition that might interfere with participation * Failure to complete self monitoring diary for 1 week * Plans to move out of the area in the upcoming 18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026