NCT01172834

Brief Summary

Strong evidence shows that physical activity (PA) has favorable psychological and health related outcomes. However, most employees do not perform enough PA to achieve health and well being benefits. Worksite interventions aimed at improving PA often yield modest effect sizes, and their theoretical ground is not profound. The Health Action Process Approach (HAPA), is a novel comprehensive theoretical model for health behavior change, that hasn't been studied as a whole in a worksite intervention study. The objectives of the proposed study are:

  1. 1.To develop a coaching-based group intervention that will be both grounded in theory (HAPA) as well as applicable.
  2. 2.To evaluate the feasibility of conducting this intervention among employed hospital nurses, using a randomized controlled design, interviews and other evaluation procedures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 30, 2010

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

July 18, 2010

Last Update Submit

July 29, 2010

Conditions

Keywords

Nurses

Outcome Measures

Primary Outcomes (4)

  • Metabolic Syndrome Ratings

    (Blood pressure, Sugar levels, HDL, Triglycerides, Weight)

    Time 0

  • Metabolic Syndrome Ratings

    (Blood pressure, Sugar levels, HDL, Triglycerides, Weight)

    Time 1 - 3 months Follow up

  • Metabolic Syndrome Ratings

    (Blood pressure, Sugar levels, HDL, Triglycerides, Weight)

    Time 2 - 6 Months Follow up

  • Metabolic Syndrome Ratings

    (Blood pressure, Sugar levels, HDL, Triglycerides, Weight)

    Time 3 - 9 Months Follow up

Secondary Outcomes (13)

  • Organizational Behavior Ratings

    Time 0

  • Psychological Ratings

    Time 0

  • Demographic ratings

    Time 0

  • Coaching Process Ratings

    Time 0

  • Organizational Behavior Ratings

    Time 1 - 3 months follow up

  • +8 more secondary outcomes

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL
Behavioral: Health Coaching

Interventions

Health CoachingBEHAVIORAL

A manual-driven group Health Coaching intervention. Once a week for 3 months.

Lifestyle counseling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses working in a full time capacity at Tel-Aviv Sourasky Medical Center.

You may not qualify if:

  • None nurses or nurses working part-time at Tel-Aviv Sourasky Medical Center.
  • Nurses not working at Tel-Aviv Sourasky Medical Center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Study Officials

  • Izthak Shapira, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 18, 2010

First Posted

July 30, 2010

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

July 30, 2010

Record last verified: 2010-07

Locations