Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care (Tracking)
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ClinicalTrials.gov Identifier: NCT01646086 |
Recruitment Status
:
Completed
First Posted
: July 20, 2012
Last Update Posted
: December 2, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Weight Loss | Behavioral: 12 month behavioral weight loss intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 339 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | October 2015 |
Arm | Intervention/treatment |
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Experimental: weekly weight tracking
12 month behavioral weight loss intervention
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Behavioral: 12 month behavioral weight loss intervention
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.
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Active Comparator: daily weight tracking
12 month behavioral weight loss intervention
|
Behavioral: 12 month behavioral weight loss intervention
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.
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Active Comparator: no weight tracking
12 month behavioral weight loss intervention
|
Behavioral: 12 month behavioral weight loss intervention
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.
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- Change in Body Weight Over Time [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]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
- Demographic Measures [ Time Frame: baseline ]Age, sex, marital status, employment status, income level (categorical), race, and ethnicity will be assessed by self-report at baseline
- Weight Tracking and Self-Monitoring Adherence [ Time Frame: throughout intervention ]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.
- Perceptions of Weight Tracking [ Time Frame: 6 months, 12 months, 18 months, and 24 months ]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)
- Barriers to Weight Tracking [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]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.
- Self-Efficacy for Weight Loss Behaviors [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]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).
- Routine Health Habits [ Time Frame: baseline, 12 months, and 24 months ]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.
- Dietary Intake [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]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.
- Physical Activity [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]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.
- Body Image [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]The Appearance Evaluation subscale of the Multidimensional Body-Self-Relations Questionnaire will assess body image.
- Self-Esteem [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]The Rosenberg Self-Esteem Scale (Rosenberg, 1979) will rate global self-esteem and will be used to track well-being during the study.
- Depression [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]The Beck Depression Inventory (BDI-II) will assess depressive symptoms that may change over the course of the study period.
- Anxiety [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]The Beck Anxiety Inventory (BAI) will assess anxiety symptoms that may change over the study.
- Mood States [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]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).
- Life Events [ Time Frame: baseline, 12 months, and 24 months ]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).
- Eating Disorder Symptoms [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]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.

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646086
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55415 |
Principal Investigator: | Jennifer Linde, PhD | University of Minnesota - Clinical and Translational Science Institute |
Additional Information:
Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT01646086 History of Changes |
Other Study ID Numbers: |
1R01DK093586 ( U.S. NIH Grant/Contract ) |
First Posted: | July 20, 2012 Key Record Dates |
Last Update Posted: | December 2, 2015 |
Last Verified: | November 2015 |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Weight Loss Self-Weighing Weight Tracking |
Additional relevant MeSH terms:
Body Weight Weight Loss Signs and Symptoms Body Weight Changes |