Weight LossNCT01966926
Self-Weighing Instruction Feasibility Study
A study testing weighing frequency instructions and tips in people with Weight Loss and Body Weight, run by University of Minnesota at 1 site in United States.
Trial summary
Scant data have been reported on the effects of weight self-monitoring during weight control. The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing? Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Body Weight
- What is being tested?
- weighing frequency instructions and tips
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 25 and 35 kg/m2
Who cannot join
- Current weight loss program participation
- Chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication)
- Current or past eating disorder
- Current pregnancy or pregnant in past year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Scant data have been reported on the effects of weight self-monitoring during weight control. The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?
Read the detailed description
This study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months. It was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions. Knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.
- Conditions
- Weight Loss, Body Weight
- Being tested
- weighing frequency instructions and tips
- Keywords
- self monitoring, self weighing, weight tracking, psychosocial outcomes, feasibility
- Medical subject headings
- Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weighing frequency instructions and tipsBehavioural
Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Daily Weight Tracking | Experimental | weighing frequency instructions and tips Receives: Behavioral: weighing frequency instructions and tips |
| Weekly Weight Tracking | Experimental | weighing frequency instructions and tips Receives: Behavioral: weighing frequency instructions and tips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Weight Tracking Instructions
Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).
Measured: 6 months
Secondary outcomes (5)
Changes in Depression Ratings
Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA). Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms. Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.
Measured: baseline to 6 months
Changes in Anxiety
Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA. Possible scores on the scale range from 0-63. Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.
Measured: baseline to 6 months
Changes in Body Image
Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire. The subscale has a range of 0 to 42, with higher scores indicating better body image. A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Measured: baseline to 6 months
Changes in Barriers to Weight Tracking
Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study. The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing. A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Measured: baseline to 6 months
Changes in Perceptions of Weight Tracking
Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study. The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking. A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Measured: three to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer A Linde, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966926
- Sponsor's protocol ID
- 0807S41483
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2013
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Weighing Instruction Feasibility Study
- ClinicalTrials.gov ID
- NCT01966926
- Acronym / sponsor ID
- 0807S41483
- Conditions
- Weight Loss, Body Weight
- Keywords
- self monitoring, self weighing, weight tracking, psychosocial outcomes, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 7 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scant data have been reported on the effects of weight self-monitoring during weight control. The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?
Detailed description
This study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months. It was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions. Knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Weight Tracking | Experimental | Behavioral: weighing frequency instructions and tipsweighing frequency instructions and tips |
| Weekly Weight Tracking | Experimental | Behavioral: weighing frequency instructions and tipsweighing frequency instructions and tips |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index between 25 and 35 kg/m2
Key exclusion criteria (4 listed)
- Current weight loss program participation
- Chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication)
- Current or past eating disorder
- Current pregnancy or pregnant in past year
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 |
|---|---|---|
| weighing frequency instructions and tipsWeekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks | Behavioural | Daily Weight Tracking, Weekly Weight Tracking |
Primary outcome
Adherence to Weight Tracking Instructions
Time frame: 6 months
Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).
5 secondary outcomes
Changes in Depression Ratings
Time frame: baseline to 6 months
Changes in Anxiety
Time frame: baseline to 6 months
Changes in Body Image
Time frame: baseline to 6 months
Changes in Barriers to Weight Tracking
Time frame: baseline to 6 months
Changes in Perceptions of Weight Tracking
Time frame: three to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer A Linde, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weighing frequency instructions and tips in people with Weight Loss and Body Weight, run by University of Minnesota 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 1 inclusion and 4 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 1 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 7 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to Weight Tracking Instructions (time frame: 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 1 Nov 2019.