what things are important to monitor/evaluate during weight loss
Brief 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 education confronting the current standard of care (weekly weight tracking) and an alternative way of care (no weight tracking).
The investigators postulate that daily weight tracking will boost ongoing awareness of and engagement in dietary intake and physical activeness monitoring, thus improving weight loss outcomes. The central hypothesis of the study is that daily weight tracking volition 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 | Non Applicable |
Detailed Clarification:
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 lodge to improve weight loss interventions are crucial. Frequency of tracking body weight presents itself as a prime number target for behavioral enhancement during weight loss. Daily self-monitoring (e.g., of dietary intake and physical activity) is already well-established as a primal component of the behavioral weight loss process. However, the electric current standard of care in behavioral weight loss with regard to weighing is weekly tracking of weight, and some programs caution confronting whatever weight tracking. It has been suggested that frequent weight tracking may accept a negative impact on mental health and outcomes during weight loss, simply in that location are minimal data that address this concern experimentally in the context of an active weight loss program. Observational show from behavioral weight command trials and community studies suggests that greater frequency of tracking weight is associated with better weight outcomes. Stronger experimental bear witness is needed to establish a causal link between weight tracking and weight outcomes and to elucidate the impact on mental wellness during weight loss. To accomplish the long-term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking educational activity against the current standard of intendance (weekly weight tracking) and an alternating model of care with very express data (no weight tracking). In pursuit of report goals, 336 overweight and obese adults volition be recruited and randomized to i of 3 12-month weight loss interventions with a 12-calendar month follow-upwardly (24 months total fourth dimension in study): the standard of care (weekly weight tracking during weight loss), an enhanced condition (daily weight tracking during weight loss), or a comparing condition (no weight tracking during weight loss). The rationale behind this proposal is that inside the context of social ecology and a social-cognitive framework of behavior change, enhancement of this key environmental feature (i.eastward., the weight tracking environs) during weight loss will contribute to success past promoting self-efficacy for this critical behavior. Specific aims of the study will seek to make up one's mind the effects of weight tracking frequency on the weight loss process and outcomes, also as to elucidate the effects of weight tracking frequency on mental health during weight loss. This study will accept the expected effect of enhancing the standard of care for weight loss, leading to ameliorate weight control for overweight and obese adults and thus directly mitigating the public wellness impact of the obesity crisis.
| Report Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 339 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open up Characterization) |
| Primary Purpose: | Treatment |
| Official Title: | Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care |
| Study Beginning Date : | July 2012 |
| Actual Primary Completion Date : | September 2015 |
| Actual Study Completion Date : | October 2015 |
Resources links provided by the National Library of Medicine 
| Arm | Intervention/handling |
|---|---|
| Experimental: weekly 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 beginning six months, and so biweekly for 2 months and monthly for the remaining four months of the 12-calendar month handling period. Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity. Participants will be asked to continue daily diet and physical action logs. |
| Active Comparator: daily weight tracking 12 calendar 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 twenty persons; groups volition meet weekly for the commencement 6 months, then biweekly for two months and monthly for the remaining iv months of the 12-month treatment period. Session content volition exist centered on behavioral goal setting and attention to caloric intake and physical activeness. Participants will be asked to continue daily diet and concrete activity logs. |
| Agile Comparator: no weight tracking 12 calendar 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 encounter in groups of up to 20 persons; groups volition meet weekly for the first six months, and then biweekly for two months and monthly for the remaining 4 months of the 12-month treatment period. Session content will exist centered on behavioral goal setting and attention to caloric intake and concrete activity. Participants will exist asked to proceed daily nutrition and concrete activity logs. |
Principal Outcome Measures :
- Modify in Torso Weight Over Time [ Time Frame: baseline, half-dozen 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 lite 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
Secondary Outcome Measures :
- Demographic Measures [ Time Frame: baseline ]
Historic period, sex, marital status, employment status, income level (chiselled), race, and ethnicity will exist assessed by self-written report at baseline
- Weight Tracking and Cocky-Monitoring Adherence [ Fourth dimension Frame: throughout intervention ]
Cocky-monitoring data on diet, physical activity, and weight from electronic or paper records will be recorded past interventionists at each session by compiling printouts of electronic records from websites supported by electronic monitoring tools, and by photocopying newspaper diaries for participants without electronic monitoring tools.
- Perceptions of Weight Tracking [ Time Frame: 6 months, 12 months, 18 months, and 24 months ]
Participants consummate an eight-item questionnaire to appraise behavior nigh their weight tracking assignment during the report. The measure asks participants to rate daily, weekly, or no weight tracking in terms of ease, interest level, power to remember, awareness, advantage value, usefulness, understanding, and how motivated they are to appoint 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; Elderberry et al., 2007)
- Barriers to Weight Tracking [ Time Frame: baseline, 6 months, 12 months, xviii months, and 24 months ]
To elucidate factors that may impede date in daily or weekly weight tracking, participants will complete an assessment of perceived barriers to tracking weight. Items for this measure were adjusted from a measure of barriers to nutrition and exercise developed past a member of the inquiry team and used in numerous weight loss studies These items volition provide feedback on factors that may interfere with weight tracking and volition provide guidance for adaptation and utilize of weight tracking instructions for future interventions.
- Self-Efficacy for Weight Loss Behaviors [ Time Frame: baseline, vi months, 12 months, xviii months, and 24 months ]
Self-efficacy for dietary intake, physical activity, and weight tracking behaviors volition exist assessed using a 15-detail scale developed by members of the enquiry team (Linde et al., 2006).
- Routine Health Habits [ Time Frame: baseline, 12 months, and 24 months ]
Participants will complete brief screening items adult for the study to assess smoking status, sedentary behavior (television viewing) and days per week of engaging in weight command behaviors, including diet and physical activeness monitoring. Weight tracking frequency (never, every other calendar month, monthly, weekly, or daily) and number of torso weight scales at dwelling house will also be assessed.
- Dietary Intake [ Time Frame: baseline, half dozen 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 Nutrition*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 call up 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 exist 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.m., Harris et al., 1994). A subset of 168 participants (50%; 56 per treatment condition) will be randomized to a seven-day accelerometer protocol at baseline and 12 months to enhance physical action measurement during active weight loss, to elucidate whatever changes in daily patterning of activity that might occur during intervention.
- Body Image [ Time Frame: baseline, 6 months, 12 months, xviii months, and 24 months ]
The Advent Evaluation subscale of the Multidimensional Torso-Self-Relations Questionnaire volition assess body image.
- Cocky-Esteem [ Time Frame: baseline, half-dozen months, 12 months, 18 months, and 24 months ]
The Rosenberg Self-Esteem Scale (Rosenberg, 1979) will charge per unit global self-esteem and will be used to track well-being during the study.
- Depression [ Time Frame: baseline, half-dozen months, 12 months, eighteen months, and 24 months ]
The Brook Depression Inventory (BDI-II) will assess depressive symptoms that may change over the class of the study period.
- Feet [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ]
The Beck Anxiety Inventory (BAI) will assess anxiety symptoms that may alter over the study.
- Mood States [ Time Frame: baseline, half dozen months, 12 months, 18 months, and 24 months ]
The Positive and Negative Bear upon Schedule - Expanded Grade (PANAS-X) volition be administered every bit a momentary assessment of mood during randomly selected intervention sessions. The measure, consisting of lx adjectives that are rated on a five-betoken Likert scale (from 1=very slightly or not at all to 5=extremely), assesses positive and negative touch, basic negative emotions (fright, hostility, guilt, sadness), basic positive emotions (joviality, self-assurance, considerateness), and additional mood states (shyness, fatigue, placidity, surprise).
- Life Events [ Time Frame: baseline, 12 months, and 24 months ]
The Life Experiences Survey (Sarason et al., 1978) volition assess a wide range of life changes and events that could bear on participation in weight tracking or other written report recommendations. We wait that participants who endorse a greater number of stressful life events will take poorer adherence, volition exist 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, xviii months, and 24 months ]
Measures used to screen participants prior to report entry will be repeated during the trial for ongoing monitoring. These include the Questionnaire on Eating and Weight Patterns to assess rampage eating, and the Scoff Eating Disorder Screening Questionnaire to assess presence of symptoms associated with anorexia or bulimia.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to bring together a written report. To learn more about this study, you or your dr. may contact the study research staff using the contacts provided below. For general information, Acquire Virtually Clinical Studies.
| Ages Eligible for Report: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yeah |
Inclusion Criteria:
- women and men
- 18-64 years of age
- BMI betwixt 25.0 and 39.9 kg/m2 (overweight to obese)
- interest in joining a weight loss program
- have a computer, e-mail, and wifi connectedness at dwelling house
- live in the Minneapolis/Saint Paul, Minnesota surface area
Exclusion Criteria:
- weight in the underweight to depression normal (BMI < 22) or morbidly obese (BMI > 35) ranges
- current eating disorder or history of eating disorders
- electric current major depression or psychotic disorder diagnosis
- electric current cardiovascular illness or diabetes diagnosis
- current participation in a weight loss programme
- current pregnancy
- previous weight loss surgery
Data from the National Library of Medicine
To learn more about this report, you or your doctor may contact the report inquiry staff using the contact information provided by the sponsor.
Please refer to this written report by its ClinicalTrials.gov identifier (NCT number): NCT01646086
| United States, Minnesota | |
| Academy of Minnesota | |
| Minneapolis, Minnesota, U.s., 55415 | |
University of Minnesota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
| Principal Investigator: | Jennifer Linde, PhD | Academy of Minnesota |
| Responsible Party: | University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01646086 |
| Other Study ID Numbers: | 1106S01462 1R01DK093586 ( U.S. NIH Grant/Contract ) |
| First Posted: | July xx, 2012 Central Tape Dates |
| Last Update Posted: | Nov 1, 2019 |
| Last Verified: | Oct 2019 |
Keywords provided past Academy of Minnesota:
| Weight Loss Cocky-Weighing Weight Tracking |
Additional relevant MeSH terms:
| Body Weight Weight Loss Body Weight Changes |
Source: https://clinicaltrials.gov/ct2/show/NCT01646086
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