NCT01487538

Brief Summary

The purpose of this study is to compare an technology-based weight maintenance intervention using action plans, videos discussion boards and health behavior tracking (weight, calories in and out, pedometer steps) with a technology-based standard advice group to facilitate health management, resourcefulness and health status for rural middle-aged women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 30, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

November 30, 2011

Last Update Submit

August 30, 2023

Conditions

Body Weight Changes

Outcome Measures

Primary Outcomes (1)

  • weight maintenance

    Weight maintenance (no significant change in weight from baseline which corresponds to a weight gain of less than 2.3 kg from baseline over the course of the study)

    baseline, 3 months, 6 months

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention will be delivered through action plans, videos, discussion boards and health behavior tracking (weight, calories in and out, pedometer steps) to facilitate health management, resourcefulness and health status.

Behavioral: VideosBehavioral: Action PlansBehavioral: Discussion BoardsBehavioral: Health behavior tracking

Standard Advice Group

ACTIVE COMPARATOR

Standard advice group receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.

Behavioral: Health behavior tracking

Interventions

VideosBEHAVIORAL

Provide information on physical activity, diet, calorie tracking to support weight maintenance in rural women.

intervention group
Action PlansBEHAVIORAL

Online action plans will be used by subjects to set and evaluate physical activity goals

intervention group
Discussion BoardsBEHAVIORAL

forum to exchange information and experiences

intervention group
Health behavior trackingBEHAVIORAL

online tracking of weight for both intervention and standard advice group. In addition, the intervention group will also track their calories in and out and their pedometer steps

Standard Advice Groupintervention group

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women:
  • aged 40-64 years;
  • reported intentional weight loss of 5-10% of initial body weight within previous 6 months;
  • residing in a rural county (population \< 50,000 residents) or rural community (population less than 2,500) within driving distance of a UNMC College of Nursing campus;
  • ability to communicate in English (verbal and written);
  • ambulatory and can walk at least one block without the use of an assistive device, such as a cane, walker, or wheelchair;
  • have access to the internet and current email account; and
  • answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active.

You may not qualify if:

  • instructed by a physician not to exercise;
  • presence of chest pain, shortness of breath, or feelings of light-headedness upon exertion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast District Health Department

Auburn, Nebraska, 68305, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Teresa Hultquist, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 7, 2011

Study Start

April 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

US(1)