Body Weight ChangesNCT01487538
Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
A study testing Videos, Action Plans and Discussion Boards in people with Body Weight Changes, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Videos, Action Plans and Discussion Boards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2012to 1 Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- instructed by a physician not to exercise;
- presence of chest pain, shortness of breath, or feelings of light-headedness upon exertion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast District Health Department
Auburn, Nebraska, 68305
About this study
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.
Read the detailed description
The purpose of this research project is to evaluate the influence of a theory-based intervention using the Health Effects of Life Transitions for Women Model to promote maintenance of initial weight loss. The intervention will be designed to promote physical activity to prevent weight regain among an underserved and vulnerable population of rural, mid-life women. The intervention 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 will be compared with the standard advice group who receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.
- Conditions
- Body Weight Changes
- Being tested
- Videos, Action Plans, Discussion Boards, Health behavior tracking
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideosBehavioural
Provide information on physical activity, diet, calorie tracking to support weight maintenance in rural women.
Action PlansBehavioural
Online action plans will be used by subjects to set and evaluate physical activity goals
Discussion BoardsBehavioural
forum to exchange information and experiences
Health behavior trackingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Videos; Behavioral: Action Plans; Behavioral: Discussion Boards; Behavioral: 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. Receives: Behavioral: Health behavior tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study start1 Apr 2012
- Primary completion1 Feb 2014
- Study completion1 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Teresa Hultquist, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487538
- Sponsor's protocol ID
- 0175-09-FB
- Other IDs
- 5P20NR011404
- Status last verified
- Aug 2023
- First submitted
- 30 Nov 2011
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
- ClinicalTrials.gov ID
- NCT01487538
- Acronym / sponsor ID
- 0175-09-FB
- Conditions
- Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Feb 2014 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this research project is to evaluate the influence of a theory-based intervention using the Health Effects of Life Transitions for Women Model to promote maintenance of initial weight loss. The intervention will be designed to promote physical activity to prevent weight regain among an underserved and vulnerable population of rural, mid-life women. The intervention 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 will be compared with the standard advice group who receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Videos, Behavioral: Action Plans, Behavioral: Discussion Boards, Behavioral: Health behavior trackingThe 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. |
| Standard Advice Group | Active comparator | Behavioral: Health behavior trackingStandard advice group receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (2 listed)
- instructed by a physician not to exercise;
- presence of chest pain, shortness of breath, or feelings of light-headedness upon exertion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideosProvide information on physical activity, diet, calorie tracking to support weight maintenance in rural women. | Behavioural | intervention group |
| Action PlansOnline action plans will be used by subjects to set and evaluate physical activity goals | Behavioural | intervention group |
| Discussion Boardsforum to exchange information and experiences | Behavioural | intervention group |
| Health behavior trackingonline 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 | Behavioural | Standard Advice Group, intervention group |
Primary outcome
weight maintenance
Time frame: baseline, 3 months, 6 months
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Hultquist, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videos, Action Plans and Discussion Boards in people with Body Weight Changes, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight maintenance (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.