ObesityLEVANCT01343238
Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum
A study testing Diet, Exercise and Diet and Exercise in people with Obesity, run by Göteborg University at 1 site in Sweden.
Trial summary
The study will investigate whether physical exercise, or dietary restrictions, or a combination of both, among overweight and obese postpartum women lead to a significantly larger reduction in weight in a longer perspective, compared to similar women not receiving the intervention. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Diet, Exercise and Diet and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- May 2007to Jun 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prepregnant BMI 25-35
- non smoking, single term birth
- intention to breastfeed exclusively for 6 mo
Who cannot join
- Diseases or medication in mother or child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study
The study will investigate whether physical exercise, or dietary restrictions, or a combination of both, among overweight and obese postpartum women lead to a significantly larger reduction in weight in a longer perspective, compared to similar women not receiving the intervention. The study also will investigate the effects on body composition, cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68 women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1) physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr after trial initiation. To date only studies showing short term (12 wk) effects exist. Our study is the first to include four intervention groups, so that separate effects of physical activity and dietary restriction and their interaction, can be assessed. Further, the investigators will estimate effects on body composition taking body water into account and estimate total energy expenditure with higher precision than previously. Overweight and obesity is an escalating problem in Sweden. Sustainable weight reduction programs are urgently needed. During the postpartum period, women may be motivated to lose weight. Information aimed at promoting life style changes among overweight and obese women could in a longer perspective be integrated in the regular maternal health care in Sweden.
- Conditions
- Obesity
- Being tested
- Diet, Exercise, Diet and Exercise
- Keywords
- obesity, diet, exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
12 week diet behavior modification
ExerciseBehavioural
12 week exercise behavioral intervention
Diet and ExerciseBehavioural
12 week diet and exercise behavioral modification intervention
| Study group | Role | What they receive |
|---|---|---|
| Diet | Experimental | 12 week diet modification intervention by dietician Receives: Behavioral: Diet |
| Exercise | Experimental | 12 week physical exercise modification intervention by physical therapist Receives: Behavioral: Exercise |
| Diet and Exercise | Experimental | 12 week diet and exercise behavioral modification by dietician and physical therapist Receives: Behavioral: Diet and Exercise |
| Control | No intervention | Standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight loss after 12 weeks intervention
Measured: 12 weeks
Secondary outcomes (1)
body composition
Change in body composition after 12 weeks intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startMay 2007
- Primary completionAug 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
- Investigators
- Anna Winkvist, PhD, Principal investigator, The Unviersity of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343238
- Sponsor's protocol ID
- K2009-70X-21091-01-3
- Other IDs
- FAS Dnr: 2006-0339
- Acronym
- LEVA
- Status last verified
- Sep 2016
- First submitted
- 26 Apr 2011
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Brekke HK, Bertz F, Rasmussen KM, Bosaeus I, Ellegard L, Winkvist A. Diet and exercise interventions among overweight and obese lactating women: randomized trial of effects on cardiovascular risk factors. PLoS One. 2014 Feb 7;9(2):e88250. doi: 10.1371/journal.pone.0088250. eCollection 2014.
PubMed 24516621Hagberg LA, Brekke HK, Bertz F, Winkvist A. Cost-utility analysis of a randomized controlled weight loss trial among lactating overweight/obese women. BMC Public Health. 2014 Jan 15;14:38. doi: 10.1186/1471-2458-14-38.
PubMed 24428802Winkvist A, Bertz F, Ellegard L, Bosaeus I, Brekke HK. Metabolic risk profile among overweight and obese lactating women in Sweden. PLoS One. 2013 May 7;8(5):e63629. doi: 10.1371/journal.pone.0063629. Print 2013.
PubMed 23667649Bertz F, Brekke HK, Ellegard L, Rasmussen KM, Wennergren M, Winkvist A. Diet and exercise weight-loss trial in lactating overweight and obese women. Am J Clin Nutr. 2012 Oct;96(4):698-705. doi: 10.3945/ajcn.112.040196. Epub 2012 Sep 5.
PubMed 22952179
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study
- ClinicalTrials.gov ID
- NCT01343238
- Acronym / sponsor ID
- LEVA / K2009-70X-21091-01-3
- Conditions
- Obesity
- Keywords
- obesity, diet, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Council for Working Life and Social Research
- Study start
- May 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Apr 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 study will investigate whether physical exercise, or dietary restrictions, or a combination of both, among overweight and obese postpartum women lead to a significantly larger reduction in weight in a longer perspective, compared to similar women not receiving the intervention. The study also will investigate the effects on body composition, cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68 women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1) physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr after trial initiation. To date only studies showing short term (12 wk) effects exist. Our study is the first to include four intervention groups, so that separate effects of physical activity and dietary restriction and their interaction, can be assessed. Further, the investigators will estimate effects on body composition taking body water into account and estimate total energy expenditure with higher precision than previously. Overweight and obesity is an escalating problem in Sweden. Sustainable weight reduction programs are urgently needed. During the postpartum period, women may be motivated to lose weight. Information aimed at promoting life style changes among overweight and obese women could in a longer perspective be integrated in the regular maternal health care in Sweden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet | Experimental | Behavioral: Diet12 week diet modification intervention by dietician |
| Exercise | Experimental | Behavioral: Exercise12 week physical exercise modification intervention by physical therapist |
| Diet and Exercise | Experimental | Behavioral: Diet and Exercise12 week diet and exercise behavioral modification by dietician and physical therapist |
| Control | No intervention | –Standard procedure |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- prepregnant BMI 25-35
- non smoking, single term birth
- intention to breastfeed exclusively for 6 mo
Key exclusion criteria (1 listed)
- Diseases or medication in mother or child
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 |
|---|---|---|
| Diet12 week diet behavior modification | Behavioural | Diet |
| Exercise12 week exercise behavioral intervention | Behavioural | Exercise |
| Diet and Exercise12 week diet and exercise behavioral modification intervention | Behavioural | Diet and Exercise |
Primary outcome
Body weight
Time frame: 12 weeks
Weight loss after 12 weeks intervention
1 secondary outcome
body composition
Time frame: 12 weeks
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 9 Sep 2016.
- Derived from this study: PubMed 24516621Brekke HK, Bertz F, Rasmussen KM, Bosaeus I, Ellegard L, Winkvist A. Diet and exercise interventions among overweight and obese lactating women: randomized trial of effects on cardiovascular risk factors. PLoS One. 2014 Feb 7;9(2):e88250. doi: 10.1371/journal.pone.0088250. eCollection 2014.
- Derived from this study: PubMed 24428802Hagberg LA, Brekke HK, Bertz F, Winkvist A. Cost-utility analysis of a randomized controlled weight loss trial among lactating overweight/obese women. BMC Public Health. 2014 Jan 15;14:38. doi: 10.1186/1471-2458-14-38.
- Derived from this study: PubMed 23667649Winkvist A, Bertz F, Ellegard L, Bosaeus I, Brekke HK. Metabolic risk profile among overweight and obese lactating women in Sweden. PLoS One. 2013 May 7;8(5):e63629. doi: 10.1371/journal.pone.0063629. Print 2013.
- Derived from this study: PubMed 22952179Bertz F, Brekke HK, Ellegard L, Rasmussen KM, Wennergren M, Winkvist A. Diet and exercise weight-loss trial in lactating overweight and obese women. Am J Clin Nutr. 2012 Oct;96(4):698-705. doi: 10.3945/ajcn.112.040196. Epub 2012 Sep 5.
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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.
Anna Winkvist, PhD principal investigator
The Unviersity of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Exercise and Diet and Exercise in people with Obesity, run by Göteborg University at 1 site in Sweden.
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 3 inclusion and 1 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 9 Sep 2016. 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 Sweden. 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?
Body weight (time frame: 12 weeks). 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 NCT01343238, which also lists 4 linked publications.
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 9 Sep 2016.