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Weight LossTrackingNCT01646086

Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care

A study testing 12 month behavioral weight loss intervention in people with Weight Loss, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To achieve the long term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternative mode of care (no weight tracking). 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
What is being tested?
12 month behavioral weight loss intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
339 participants
Where
1 siteUnited States
Study dates
Jul 2012to Oct 2015
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 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • women and men
  • 18-64 years of age
  • BMI between 25.0 and 39.9 kg/m2 (overweight to obese)
  • interest in joining a weight loss program
  • have a computer, email, and wifi connection at home
  • live in the Minneapolis/Saint Paul, Minnesota area

Who cannot join

  • weight in the underweight to low normal (BMI < 22) or morbidly obese (BMI > 35) ranges
  • current eating disorder or history of eating disorders
  • current major depression or psychotic disorder diagnosis
  • current cardiovascular disease or diabetes diagnosis
  • current participation in a weight loss program
  • current pregnancy
  • previous weight loss surgery

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55415

Other trials in United States

About this study

To achieve the long term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternative mode of care (no weight tracking).

The investigators postulate that daily weight tracking will boost ongoing awareness of and engagement in dietary intake and physical activity monitoring, thus improving weight loss outcomes. The central hypothesis of the study is that daily weight tracking will improve weight loss processes and outcomes relative to less frequent weight tracking, without adverse effects.

Read the detailed description

Given the pernicious reach of obesity and the evidence that current behavioral treatments are modestly effective at changing weight, efforts to refine behavioral recommendations in order to improve weight loss interventions are crucial. Frequency of tracking body weight presents itself as a prime target for behavioral enhancement during weight loss. Daily self-monitoring (e.g., of dietary intake and physical activity) is already well-established as a central component of the behavioral weight loss process. However, the current standard of care in behavioral weight loss with regard to weighing is weekly tracking of weight, and some programs caution against any weight tracking. It has been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss, but there are minimal data that address this concern experimentally in the context of an active weight loss program. Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of tracking weight is associated with better weight outcomes. Stronger experimental evidence is needed to establish a causal link between weight tracking and weight outcomes and to elucidate the impact on mental health during weight loss. To achieve the long-term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternate model of care with very limited data (no weight tracking). In pursuit of study goals, 336 overweight and obese adults will be recruited and randomized to one of three 12-month weight loss interventions with a 12-month follow-up (24 months total time in study): the standard of care (weekly weight tracking during weight loss), an enhanced condition (daily weight tracking during weight loss), or a comparison condition (no weight tracking during weight loss). The rationale behind this proposal is that within the context of social ecology and a social-cognitive framework of behavior change, enhancement of this key environmental feature (i.e., the weight tracking environment) during weight loss will contribute to success by promoting self-efficacy for this critical behavior. Specific aims of the study will seek to determine the effects of weight tracking frequency on the weight loss process and outcomes, as well as to elucidate the effects of weight tracking frequency on mental health during weight loss. This study will have the expected outcome of enhancing the standard of care for weight loss, leading to better weight control for overweight and obese adults and thus directly mitigating the public health impact of the obesity crisis.

Conditions
Weight Loss
Being tested
12 month behavioral weight loss intervention
Keywords
Weight Loss, Self-Weighing, Weight Tracking
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12 month behavioral weight loss interventionBehavioural

    The intervention for all groups will follow a standard behavioral weight loss protocol. Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period. Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity. Participants will be asked to keep daily diet and physical activity logs.

Study groups in NCT01646086
Study groupRoleWhat they receive
weekly weight trackingExperimental12 month behavioral weight loss intervention
Receives: Behavioral: 12 month behavioral weight loss intervention
daily weight trackingActive comparator12 month behavioral weight loss intervention
Receives: Behavioral: 12 month behavioral weight loss intervention
no weight trackingActive comparator12 month behavioral weight loss intervention
Receives: Behavioral: 12 month behavioral weight loss intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Weight Over Time

    Weight (in kilograms) will be measured by study staff using a calibrated digital scales with participants wearing light clothing and no shoes. Height (in centimeters) will be measured by study staff at baseline only using a portable stadiometer. BMI (kg/m2) will be calculated from these measurements

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

Secondary outcomes (15)
  1. Demographic Measures

    Age, sex, marital status, employment status, income level (categorical), race, and ethnicity will be assessed by self-report at baseline

    Measured: baseline

  2. Weight Tracking and Self-Monitoring Adherence

    Self-monitoring data on diet, physical activity, and weight from electronic or paper records will be recorded by interventionists at each session by compiling printouts of electronic records from websites supported by electronic monitoring tools, and by photocopying paper diaries for participants without electronic monitoring tools.

    Measured: throughout intervention

  3. Perceptions of Weight Tracking

    Participants complete an 8-item questionnaire to assess beliefs about their weight tracking assignment during the study. The measure asks participants to rate daily, weekly, or no weight tracking in terms of ease, interest level, ability to remember, awareness, reward value, usefulness, understanding, and how motivated they are to engage in their assigned weight tracking frequency. These items measure aspects of cue strength and motivational value, both of which are important to the process of behavior modification within a social-ecological frame (DiClemente et al., 2001; Elder et al., 2007)

    Measured: 6 months, 12 months, 18 months, and 24 months

  4. Barriers to Weight Tracking

    To elucidate factors that may impede engagement in daily or weekly weight tracking, participants will complete an assessment of perceived barriers to tracking weight. Items for this measure were adapted from a measure of barriers to diet and exercise developed by a member of the research team and used in numerous weight loss studies These items will provide feedback on factors that may interfere with weight tracking and will provide guidance for adaptation and use of weight tracking instructions for future interventions.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  5. Self-Efficacy for Weight Loss Behaviors

    Self-efficacy for dietary intake, physical activity, and weight tracking behaviors will be assessed using a 15-item scale developed by members of the research team (Linde et al., 2006).

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  6. Routine Health Habits

    Participants will complete brief screening items developed for the study to assess smoking status, sedentary behavior (television viewing) and days per week of engaging in weight control behaviors, including diet and physical activity monitoring. Weight tracking frequency (never, every other month, monthly, weekly, or daily) and number of body weight scales at home will also be assessed.

    Measured: baseline, 12 months, and 24 months

  7. Dietary Intake

    The Diet History Questionnaire (DHQ, 2010) is a food frequency questionnaire (FFQ) that assesses usual intake and portion size of 124 foods. Responses are scored and analyzed using proprietary Diet*Calc software, which provides reasonable and valid estimates of macronutrient and caloric intake compared to 24-hour recall administrations (Millen et al., 2006) and alternate FFQ protocols (Subar et al., 2001). A subset of 168 participants (50%; 56 per treatment condition) will be randomized at baseline to a 24-hr dietary recall protocol.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  8. Physical Activity

    The Paffenbarger Activity Questionnaire (PAQ; Paffenbarger et al., 1978) will be administered to provide an estimate of calories expended per week in leisure time physical activities. The PAQ has been associated with weight loss outcomes in intervention trials (e.g., Harris et al., 1994). A subset of 168 participants (50%; 56 per treatment condition) will be randomized to a 7-day accelerometer protocol at baseline and 12 months to enhance physical activity measurement during active weight loss, to elucidate any changes in daily patterning of activity that might occur during intervention.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  9. Body Image

    The Appearance Evaluation subscale of the Multidimensional Body-Self-Relations Questionnaire will assess body image.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  10. Self-Esteem

    The Rosenberg Self-Esteem Scale (Rosenberg, 1979) will rate global self-esteem and will be used to track well-being during the study.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  11. Depression

    The Beck Depression Inventory (BDI-II) will assess depressive symptoms that may change over the course of the study period.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  12. Anxiety

    The Beck Anxiety Inventory (BAI) will assess anxiety symptoms that may change over the study.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  13. Mood States

    The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) will be administered as a momentary assessment of mood during randomly selected intervention sessions. The measure, consisting of 60 adjectives that are rated on a five-point Likert scale (from 1=very slightly or not at all to 5=extremely), assesses positive and negative affect, basic negative emotions (fear, hostility, guilt, sadness), basic positive emotions (joviality, self-assurance, attentiveness), and additional mood states (shyness, fatigue, serenity, surprise).

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

  14. Life Events

    The Life Experiences Survey (Sarason et al., 1978) will assess a broad range of life changes and events that could affect participation in weight tracking or other study recommendations. We expect that participants who endorse a greater number of stressful life events will have poorer adherence, will be less able to maintain tracking diaries, and will experience greater negative affect relative to those with fewer life events during the study (Dunkley et al., 2003; Sarason et al., 1978).

    Measured: baseline, 12 months, and 24 months

  15. Eating Disorder Symptoms

    Measures used to screen participants prior to study entry will be repeated during the trial for ongoing monitoring. These include the Questionnaire on Eating and Weight Patterns to assess binge eating, and the SCOFF Eating Disorder Screening Questionnaire to assess presence of symptoms associated with anorexia or bulimia.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionSep 2015
  4. Study completionOct 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
339 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01646086
Sponsor's protocol ID
1106S01462
Other IDs
1R01DK093586
Acronym
Tracking
Status last verified
Oct 2019
First submitted
18 Jul 2012
Last updated
1 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • Crane MM, Gavin K, Wolfson J, Linde JA. How Accurate are Recalls of Self-Weighing Frequency? Data from a 24-Month Randomized Trial. Obesity (Silver Spring). 2018 Aug;26(8):1296-1302. doi: 10.1002/oby.22239. Epub 2018 Aug 1.

    PubMed 30070045

Questions about this trial

What is this clinical trial studying?

A study testing 12 month behavioral weight loss intervention in people with Weight Loss, 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 6 inclusion and 7 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?

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?

Change in Body Weight Over Time (time frame: baseline, 6 months, 12 months, 18 months, and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01646086, which also lists 1 linked publication.

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.

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